A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer (BATMAN)
25. srpna 2017 aktualizováno: Hoffmann-La Roche
Open-Label Study of Bevacizumab (Avastin®) and Taxane Monotherapy for the First-Line Treatment of Patients With Advanced Triple Negative Breast Cancer
This open-label, multi-center study will evaluate the safety, tolerability and effect of bevacizumab (Avastin) in combination with taxane (paclitaxel/ docetaxel) monotherapy on disease progression, survival time and Karnofsky performance status in female participants with estrogen-, progesterone- and human epidermal growth factor receptor 2 (HER2)-negative (triple-negative) breast cancer.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
49
Fáze
- Fáze 4
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Bangor, Spojené království, LL57 2PD
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Cottingham, Spojené království, HU16 5JG
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Exeter, Spojené království, EX2 5DW
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Grimsby, Spojené království, DN33 2BA
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Harrogate, Spojené království, HG2 8AY
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Plymouth, Spojené království, PL6 8DH
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Portsmouth, Spojené království, PO6 3LY
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Preston, Spojené království, PR2 9HT
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Somerset, Spojené království, TA1 5DA
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Wolverhampton, Spojené království, WV10 0QP
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Ženský
Popis
Inclusion Criteria:
- Histologically confirmed triple-negative (estrogen, progesterone, and HER-2 receptor negative) adenocarcinoma of the breast in pre- or post-menopausal women with measurable or non-measurable metastatic disease
- Participant who in the Investigator's opinion requires combination therapy for their disease
- Life expectancy of greater than or equal to (>/=)12 weeks
Exclusion Criteria:
- Previous chemotherapy for metastatic breast cancer
- Participants currently undergoing radiation therapy for the treatment of metastatic disease (apart from the relief of metastatic bone pain)
- Major surgery or significant traumatic injury within 28 days prior to enrollment or anticipation of the need for major surgery during study treatment
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Bevacizumab 10 mg/kg Q2W
Participants will receive bevacizumab at a dose of 10 milligrams per kilogram (mg/kg) every 2 weeks (Q2W) as intravenous infusion along with paclitaxel every week (Q1W) or docetaxel every 3 weeks (Q3W) as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
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Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
Ostatní jména:
Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.
Docetaxel will be administered as intravenous infusion Q3W as per discretion of the treating physician.
Protocol amendment 2 (dated 17-Feb-2011) removed the option to choose docetaxel.
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Experimentální: Bevacizumab 15 mg/kg Q3W
Participants will receive bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
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Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
Ostatní jména:
Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.
Docetaxel will be administered as intravenous infusion Q3W as per discretion of the treating physician.
Protocol amendment 2 (dated 17-Feb-2011) removed the option to choose docetaxel.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2
Časové okno: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 3
Časové okno: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 4
Časové okno: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 5
Časové okno: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 6
Časové okno: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 7
Časové okno: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 8
Časové okno: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score At Cycle 9
Časové okno: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 10
Časové okno: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 11
Časové okno: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 12
Časové okno: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 13
Časové okno: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 14
Časové okno: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 15
Časové okno: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 16
Časové okno: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 17
Časové okno: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 18
Časové okno: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 20
Časové okno: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 21
Časové okno: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 22
Časové okno: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 23
Časové okno: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 24
Časové okno: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 25
Časové okno: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 26
Časové okno: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 27
Časové okno: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 28
Časové okno: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 29
Časové okno: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 30
Časové okno: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 32
Časové okno: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
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Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 36
Časové okno: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
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FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
|
Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 37
Časové okno: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
|
FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
|
Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 39
Časové okno: Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
|
FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
|
Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 42
Časové okno: Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
|
FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
|
Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
|
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Change From Baseline in FACT-B Score at Cycle 44
Časové okno: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
|
FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
|
Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 46
Časové okno: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
|
FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
|
Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at End of Study
Časové okno: Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
|
FACT-B is used for assessment of health-related QoL in participants with breast cancer.
It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score ranged from 0 to 144.
High scale score represents a better QoL.
|
Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
|
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Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2
Časové okno: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 3
Časové okno: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4
Časové okno: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5
Časové okno: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6
Časové okno: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 7
Časové okno: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8
Časové okno: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 9
Časové okno: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10
Časové okno: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 11
Časové okno: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12
Časové okno: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 13
Časové okno: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14
Časové okno: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 15
Časové okno: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 16
Časové okno: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 17
Časové okno: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18
Časové okno: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 20
Časové okno: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21
Časové okno: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 22
Časové okno: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23
Časové okno: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 24
Časové okno: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 25
Časové okno: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26
Časové okno: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27
Časové okno: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 28
Časové okno: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29
Časové okno: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30
Časové okno: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 32
Časové okno: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36
Časové okno: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 37
Časové okno: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 39
Časové okno: Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 40
Časové okno: Baseline, Cycle 40 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 40 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 42
Časové okno: Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 44
Časové okno: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 46
Časové okno: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study
Časové okno: Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state.
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
|
Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
|
|
Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2
Časové okno: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 3
Časové okno: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 4
Časové okno: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 5
Časové okno: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 6
Časové okno: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 7
Časové okno: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 8
Časové okno: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 9
Časové okno: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 10
Časové okno: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 11
Časové okno: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 12
Časové okno: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 13
Časové okno: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 14
Časové okno: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 15
Časové okno: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 16
Časové okno: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 17
Časové okno: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 18
Časové okno: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 20
Časové okno: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 21
Časové okno: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 22
Časové okno: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 23
Časové okno: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 24
Časové okno: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 25
Časové okno: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 26
Časové okno: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 27
Časové okno: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 28
Časové okno: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 29
Časové okno: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 30
Časové okno: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 32
Časové okno: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 36
Časové okno: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 37
Časové okno: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 39
Časové okno: Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 40
Časové okno: Baseline, Cycle 40 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 40 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 42
Časové okno: Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 44
Časové okno: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 46
Časové okno: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at End of Study
Časové okno: Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
|
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value.
The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
|
Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of Participants Who Died Due to Any Cause
Časové okno: Baseline up to death (overall approximately 5 years and 9 months)
|
Baseline up to death (overall approximately 5 years and 9 months)
|
|
|
Overall Survival
Časové okno: Baseline up to death (overall approximately 5 years and 9 months)
|
Overall survival was defined as the time from start of taxane plus bevacizumab therapy to death due to any cause.
Overall survival was calculated in months as (date of death from any cause - date of first administration of taxane or bevacizumab + 1) / 30.4375 and rounded to 1 decimal place.
Participants for whom no death was captured on the clinical database were censored at the last date they were known to be alive.
|
Baseline up to death (overall approximately 5 years and 9 months)
|
|
Percentage of Participants With Disease Progression
Časové okno: Baseline up to disease progression (overall approximately 5 years and 9 months)
|
Disease progression was defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 mm of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
|
Baseline up to disease progression (overall approximately 5 years and 9 months)
|
|
Time to Disease Progression
Časové okno: Baseline up to disease progression (overall approximately 5 years and 9 months)
|
Time to disease progression was defined as the time from the start of taxane plus bevacizumab therapy to investigator assessed disease progression and was calculated in months as (date of Investigator assessed disease progression - date of first administration of taxane or bevacizumab + 1) / 30.4375 and rounded to 1 decimal place.
Participants who had not progressed at the time of study completion (including participants who had died before progressive disease) or who were lost to follow-up were censored at the last bevacizumab administration date.
Disease progression was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
|
Baseline up to disease progression (overall approximately 5 years and 9 months)
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
Časové okno: Baseline, Cycle 1 thereafter every cycle up to Cycle 47 (Cycle length=2 and 3 weeks), end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
|
Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment.
Karnofsky performance score is 11 level score which range between 0% (death) to 100% (no evidence of disease).
Higher score means higher ability to perform daily tasks.
|
Baseline, Cycle 1 thereafter every cycle up to Cycle 47 (Cycle length=2 and 3 weeks), end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. března 2010
Primární dokončení (Aktuální)
1. prosince 2015
Dokončení studie (Aktuální)
1. prosince 2015
Termíny zápisu do studia
První předloženo
16. března 2010
První předloženo, které splnilo kritéria kontroly kvality
25. března 2010
První zveřejněno (Odhad)
26. března 2010
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
22. března 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
25. srpna 2017
Naposledy ověřeno
1. srpna 2017
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Kožní choroby
- Novotvary
- Novotvary podle místa
- Nemoci prsu
- Novotvary prsu
- Trojité negativní novotvary prsu
- Fyziologické účinky léků
- Molekulární mechanismy farmakologického působení
- Antineoplastická činidla
- Tubulinové modulátory
- Antimitotické látky
- Modulátory mitózy
- Antineoplastické látky, fytogenní
- Antineoplastická činidla, Imunologická
- Inhibitory angiogeneze
- Činidla modulující angiogenezi
- Růstové látky
- Inhibitory růstu
- Docetaxel
- Paklitaxel
- Bevacizumab
Další identifikační čísla studie
- ML22780
- 2009-014279-37
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Rakovina prsu
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital a další spolupracovníciDokončenoPrůvodce klinickou aplikací Conebeam Breast CTČína
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH); Rising...NáborAnatomický karcinom prsu stadia II AJCC v8 | Anatomický karcinom prsu stadia III AJCC v8 | Rané stadium karcinomu prsu | Anatomic Stage I Breast Cancer American Joint Committee on Cancer (AJCC) v8Spojené státy
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Jessica Mezzanotte SharpeNáborNemalobuněčný karcinom plic | Klasický Hodgkinův lymfom | Spinocelulární karcinom v ústech | Melanom (rakovina kůže) | Rakovina prsu (Triple Negative Breast Cancer (TNBC)) | Invazivní karcinom prsu | Renální buněčný karcinom (rakovina ledvin) | Rakovina konečníku s MSI-H/dMMRSpojené státy
Klinické studie na Bevacizumab
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National Cancer Institute (NCI)Aktivní, ne náborRecidivující karcinom vejcovodů | Recidivující ovariální karcinom | Recidivující primární peritoneální karcinom | Cystadenokarcinom vaječníků z jasných buněk | Endometrioidní adenokarcinom vaječníků | Ovariální serózní cystadenokarcinom | Endometriální průhledný adenokarcinom | Endometriální serózní... a další podmínkySpojené státy
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National Cancer Institute (NCI)NRG OncologyDokončenoGlioblastom | Gliosarkom | Recidivující glioblastom | Oligodendrogliom | Giant Cell Glioblastom | Recidivující novotvar mozkuSpojené státy, Kanada
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M.D. Anderson Cancer CenterAktivní, ne náborHepatocelulární karcinom stadia IB AJCC v8 | Hepatocelulární karcinom stadia II AJCC v8 | Resekabilní hepatocelulární karcinom | Hepatocelulární karcinom stadia I AJCC v8 | Hepatocelulární karcinom stadia IA AJCC v8Spojené státy
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National Cancer Institute (NCI)DokončenoCervikální adenokarcinom | Cervikální adenoskvamózní karcinom | Spinocelulární karcinom děložního čípku, jinak nespecifikovaný | Stádium IVA rakoviny děložního čípku AJCC v6 a v7 | Recidivující cervikální karcinom | Rakovina děložního čípku stadia IV AJCC v6 a v7 | Stádium IVB rakoviny děložního čípku...Spojené státy
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Northwestern UniversityNational Cancer Institute (NCI); Ipsen BiopharmaceuticalsDokončenoRecidivující karcinom vejcovodů | Recidivující ovariální karcinom | Recidivující primární peritoneální karcinom | Karcinom vejcovodu rezistentní na platinu | Primární peritoneální karcinom rezistentní na platinu | Karcinom vaječníků rezistentní na platinu | Refrakterní ovariální karcinom | Refrakterní... a další podmínkySpojené státy
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National Cancer Institute (NCI)Aktivní, ne náborRecidivující glioblastomSpojené státy
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National Cancer Institute (NCI)Aktivní, ne náborMetastatický alveolární sarkom měkkých částí | Neresekovatelný alveolární sarkom měkkých částíSpojené státy
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Roswell Park Cancer InstituteMerck Sharp & Dohme LLC; United States Department of Defense; Celldex TherapeuticsNáborRecidivující karcinom vejcovodů | Recidivující ovariální karcinom | Recidivující primární peritoneální karcinom | Recidivující serózní adenokarcinom endometria | Jasnobuněčný adenokarcinom vaječníků | Recidivující platina-rezistentní karcinom vaječníků | Karcinom vaječníků citlivý na platinu | Recidivující... a další podmínkySpojené státy
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National Cancer Institute (NCI)DokončenoStádium IV kožního melanomu AJCC v6 a v7 | Stádium IIIC kožní melanom AJCC v7 | Neresekovatelný melanomSpojené státy