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

2017. augusztus 25. frissítette: 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.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

49

Fázis

  • 4. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

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

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Női

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Nem véletlenszerű
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 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.
Drog: Bevacizumab
Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
Más nevek:
  • Avastin
Drog: Paclitaxel
Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.
Drog: 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.
Kísérleti: 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.
Drog: Bevacizumab
Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
Más nevek:
  • Avastin
Drog: Paclitaxel
Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.
Drog: 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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Percentage of Participants Who Died Due to Any Cause
Időkeret: Baseline up to death (overall approximately 5 years and 9 months)
Baseline up to death (overall approximately 5 years and 9 months)
Overall Survival
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Hoffmann-La Roche

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2010. március 1.

Elsődleges befejezés (Tényleges)

2015. december 1.

A tanulmány befejezése (Tényleges)

2015. december 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2010. március 16.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2010. március 25.

Első közzététel (Becslés)

2010. március 26.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2018. március 22.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2017. augusztus 25.

Utolsó ellenőrzés

2017. augusztus 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • ML22780
  • 2009-014279-37

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

Klinikai vizsgálatok a Mellrák

Klinikai vizsgálatok a Bevacizumab

Keressen hasonló próbaverziókban

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

CROs by country

CROs in Bahrain

Körülmények

Ritka betegségek

Kábítószer-beavatkozások

Táplálék-kiegészítők

Szponzor / közreműködők

Helyek

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