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A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer (BATMAN)

25 augusti 2017 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

49

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Storbritannien
      • Bangor, Storbritannien, LL57 2PD
      • Cottingham, Storbritannien, HU16 5JG
      • Exeter, Storbritannien, EX2 5DW
      • Grimsby, Storbritannien, DN33 2BA
      • Harrogate, Storbritannien, HG2 8AY
      • Plymouth, Storbritannien, PL6 8DH
      • Portsmouth, Storbritannien, PO6 3LY
      • Preston, Storbritannien, PR2 9HT
      • Somerset, Storbritannien, TA1 5DA
      • Wolverhampton, Storbritannien, WV10 0QP

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: Bevacizumab
Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
Andra namn:
  • Avastin
Läkemedel: Paclitaxel
Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.
Läkemedel: Docetaxel
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.
Experimentell: 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.
Läkemedel: Bevacizumab
Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
Andra namn:
  • Avastin
Läkemedel: Paclitaxel
Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.
Läkemedel: Docetaxel
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2
Tidsram: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
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.
Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 3
Tidsram: Baseline, Cycle 3 (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 3 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 4
Tidsram: Baseline, Cycle 4 (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 4 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 5
Tidsram: Baseline, Cycle 5 (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 5 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 6
Tidsram: Baseline, Cycle 6 (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 6 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 7
Tidsram: Baseline, Cycle 7 (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 7 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 8
Tidsram: Baseline, Cycle 8 (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 8 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score At Cycle 9
Tidsram: Baseline, Cycle 9 (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 9 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 10
Tidsram: Baseline, Cycle 10 (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 10 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 11
Tidsram: Baseline, Cycle 11 (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 11 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 12
Tidsram: Baseline, Cycle 12 (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 12 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 13
Tidsram: Baseline, Cycle 13 (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 13 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 14
Tidsram: Baseline, Cycle 14 (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 14 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 15
Tidsram: Baseline, Cycle 15 (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 15 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 16
Tidsram: Baseline, Cycle 16 (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 16 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 17
Tidsram: Baseline, Cycle 17 (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 17 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 18
Tidsram: Baseline, Cycle 18 (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 18 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 20
Tidsram: Baseline, Cycle 20 (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 20 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 21
Tidsram: Baseline, Cycle 21 (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 21 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 22
Tidsram: Baseline, Cycle 22 (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 22 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 23
Tidsram: Baseline, Cycle 23 (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 23 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 24
Tidsram: Baseline, Cycle 24 (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 24 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 25
Tidsram: Baseline, Cycle 25 (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 25 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 26
Tidsram: Baseline, Cycle 26 (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 26 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 27
Tidsram: Baseline, Cycle 27 (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 27 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 28
Tidsram: Baseline, Cycle 28 (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 28 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 29
Tidsram: Baseline, Cycle 29 (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 29 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 30
Tidsram: Baseline, Cycle 30 (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 30 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 32
Tidsram: Baseline, Cycle 32 (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 32 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 36
Tidsram: Baseline, Cycle 36 (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 36 (Cycle length=2 and 3 weeks)
Change From Baseline in FACT-B Score at Cycle 37
Tidsram: 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)
Change From Baseline in FACT-B Score at Cycle 39
Tidsram: 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)
Change From Baseline in FACT-B Score at Cycle 42
Tidsram: 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)
Change From Baseline in FACT-B Score at Cycle 44
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants Who Died Due to Any Cause
Tidsram: Baseline up to death (overall approximately 5 years and 9 months)
Baseline up to death (overall approximately 5 years and 9 months)
Overall Survival
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

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Sponsor

Hoffmann-La Roche

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2010

Primärt slutförande (Faktisk)

1 december 2015

Avslutad studie (Faktisk)

1 december 2015

Studieregistreringsdatum

Först inskickad

16 mars 2010

Först inskickad som uppfyllde QC-kriterierna

25 mars 2010

Första postat (Uppskatta)

26 mars 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 mars 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 augusti 2017

Senast verifierad

1 augusti 2017

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ML22780
  • 2009-014279-37

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