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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01094184
Recruitment Status : Completed
First Posted : March 26, 2010
Results First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Bevacizumab Drug: Paclitaxel Drug: Docetaxel Phase 4

Study Design
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Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Study of Bevacizumab (Avastin®) and Taxane Monotherapy for the First-Line Treatment of Patients With Advanced Triple Negative Breast Cancer
Study Start Date : March 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Bevacizumab
Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
Other Name: Avastin

Drug: Paclitaxel
Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.

Drug: 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.
Experimental: 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.
 Drug: Bevacizumab
Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
Other Name: Avastin

Drug: Paclitaxel
Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.

Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2 [ Time Frame: 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.

  2. Change From Baseline in FACT-B Score at Cycle 3 [ Time Frame: 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.

  3. Change From Baseline in FACT-B Score at Cycle 4 [ Time Frame: 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.

  4. Change From Baseline in FACT-B Score at Cycle 5 [ Time Frame: 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.

  5. Change From Baseline in FACT-B Score at Cycle 6 [ Time Frame: 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.

  6. Change From Baseline in FACT-B Score at Cycle 7 [ Time Frame: 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.

  7. Change From Baseline in FACT-B Score at Cycle 8 [ Time Frame: 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.

  8. Change From Baseline in FACT-B Score At Cycle 9 [ Time Frame: 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.

  9. Change From Baseline in FACT-B Score at Cycle 10 [ Time Frame: 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.

  10. Change From Baseline in FACT-B Score at Cycle 11 [ Time Frame: 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.

  11. Change From Baseline in FACT-B Score at Cycle 12 [ Time Frame: 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.

  12. Change From Baseline in FACT-B Score at Cycle 13 [ Time Frame: 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.

  13. Change From Baseline in FACT-B Score at Cycle 14 [ Time Frame: 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.

  14. Change From Baseline in FACT-B Score at Cycle 15 [ Time Frame: 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.

  15. Change From Baseline in FACT-B Score at Cycle 16 [ Time Frame: 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.

  16. Change From Baseline in FACT-B Score at Cycle 17 [ Time Frame: 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.

  17. Change From Baseline in FACT-B Score at Cycle 18 [ Time Frame: 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.

  18. Change From Baseline in FACT-B Score at Cycle 20 [ Time Frame: 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.

  19. Change From Baseline in FACT-B Score at Cycle 21 [ Time Frame: 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.

  20. Change From Baseline in FACT-B Score at Cycle 22 [ Time Frame: 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.

  21. Change From Baseline in FACT-B Score at Cycle 23 [ Time Frame: 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.

  22. Change From Baseline in FACT-B Score at Cycle 24 [ Time Frame: 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.

  23. Change From Baseline in FACT-B Score at Cycle 25 [ Time Frame: 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.

  24. Change From Baseline in FACT-B Score at Cycle 26 [ Time Frame: 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.

  25. Change From Baseline in FACT-B Score at Cycle 27 [ Time Frame: 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.

  26. Change From Baseline in FACT-B Score at Cycle 28 [ Time Frame: 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.

  27. Change From Baseline in FACT-B Score at Cycle 29 [ Time Frame: 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.

  28. Change From Baseline in FACT-B Score at Cycle 30 [ Time Frame: 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.

  29. Change From Baseline in FACT-B Score at Cycle 32 [ Time Frame: 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.

  30. Change From Baseline in FACT-B Score at Cycle 36 [ Time Frame: 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.

  31. Change From Baseline in FACT-B Score at Cycle 37 [ Time Frame: 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.

  32. Change From Baseline in FACT-B Score at Cycle 39 [ Time Frame: 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.

  33. Change From Baseline in FACT-B Score at Cycle 42 [ Time Frame: 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.

  34. Change From Baseline in FACT-B Score at Cycle 44 [ Time Frame: 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.

  35. Change From Baseline in FACT-B Score at Cycle 46 [ Time Frame: 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.

  36. Change From Baseline in FACT-B Score at End of Study [ Time Frame: 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.

  37. Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2 [ Time Frame: 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.

  38. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 3 [ Time Frame: 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.

  39. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4 [ Time Frame: 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.

  40. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5 [ Time Frame: 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.

  41. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6 [ Time Frame: 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.

  42. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 7 [ Time Frame: 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.

  43. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8 [ Time Frame: 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.

  44. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 9 [ Time Frame: 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.

  45. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10 [ Time Frame: 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.

  46. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 11 [ Time Frame: 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.

  47. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12 [ Time Frame: 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.

  48. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 13 [ Time Frame: 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.

  49. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14 [ Time Frame: 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.

  50. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 15 [ Time Frame: 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.

  51. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 16 [ Time Frame: 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.

  52. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 17 [ Time Frame: 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.

  53. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18 [ Time Frame: 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.

  54. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 20 [ Time Frame: 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.

  55. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21 [ Time Frame: 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.

  56. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 22 [ Time Frame: 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.

  57. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23 [ Time Frame: 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.

  58. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 24 [ Time Frame: 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.

  59. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 25 [ Time Frame: 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.

  60. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26 [ Time Frame: 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.

  61. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27 [ Time Frame: 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.

  62. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 28 [ Time Frame: 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.

  63. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29 [ Time Frame: 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.

  64. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30 [ Time Frame: 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.

  65. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 32 [ Time Frame: 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.

  66. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36 [ Time Frame: 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.

  67. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 37 [ Time Frame: 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.

  68. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 39 [ Time Frame: 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.

  69. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 40 [ Time Frame: 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.

  70. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 42 [ Time Frame: 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.

  71. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 44 [ Time Frame: 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.

  72. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 46 [ Time Frame: 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.

  73. Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study [ Time Frame: 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.

  74. Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2 [ Time Frame: 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.

  75. Change From Baseline in EQ-5D-VAS Score at Cycle 3 [ Time Frame: 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.

  76. Change From Baseline in EQ-5D-VAS Score at Cycle 4 [ Time Frame: 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.

  77. Change From Baseline in EQ-5D-VAS Score at Cycle 5 [ Time Frame: 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.

  78. Change From Baseline in EQ-5D-VAS Score at Cycle 6 [ Time Frame: 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.

  79. Change From Baseline in EQ-5D-VAS Score at Cycle 7 [ Time Frame: 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.

  80. Change From Baseline in EQ-5D-VAS Score at Cycle 8 [ Time Frame: 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.

  81. Change From Baseline in EQ-5D-VAS Score at Cycle 9 [ Time Frame: 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.

  82. Change From Baseline in EQ-5D-VAS Score at Cycle 10 [ Time Frame: 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.

  83. Change From Baseline in EQ-5D-VAS Score at Cycle 11 [ Time Frame: 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.

  84. Change From Baseline in EQ-5D-VAS Score at Cycle 12 [ Time Frame: 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.

  85. Change From Baseline in EQ-5D-VAS Score at Cycle 13 [ Time Frame: 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.

  86. Change From Baseline in EQ-5D-VAS Score at Cycle 14 [ Time Frame: 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.

  87. Change From Baseline in EQ-5D-VAS Score at Cycle 15 [ Time Frame: 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.

  88. Change From Baseline in EQ-5D-VAS Score at Cycle 16 [ Time Frame: 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.

  89. Change From Baseline in EQ-5D-VAS Score at Cycle 17 [ Time Frame: 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.

  90. Change From Baseline in EQ-5D-VAS Score at Cycle 18 [ Time Frame: 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.

  91. Change From Baseline in EQ-5D-VAS Score at Cycle 20 [ Time Frame: 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.

  92. Change From Baseline in EQ-5D-VAS Score at Cycle 21 [ Time Frame: 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.

  93. Change From Baseline in EQ-5D-VAS Score at Cycle 22 [ Time Frame: 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.

  94. Change From Baseline in EQ-5D-VAS Score at Cycle 23 [ Time Frame: 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.

  95. Change From Baseline in EQ-5D-VAS Score at Cycle 24 [ Time Frame: 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.

  96. Change From Baseline in EQ-5D-VAS Score at Cycle 25 [ Time Frame: 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.

  97. Change From Baseline in EQ-5D-VAS Score at Cycle 26 [ Time Frame: 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.

  98. Change From Baseline in EQ-5D-VAS Score at Cycle 27 [ Time Frame: 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.

  99. Change From Baseline in EQ-5D-VAS Score at Cycle 28 [ Time Frame: 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.

  100. Change From Baseline in EQ-5D-VAS Score at Cycle 29 [ Time Frame: 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.

  101. Change From Baseline in EQ-5D-VAS Score at Cycle 30 [ Time Frame: 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.

  102. Change From Baseline in EQ-5D-VAS Score at Cycle 32 [ Time Frame: 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.

  103. Change From Baseline in EQ-5D-VAS Score at Cycle 36 [ Time Frame: 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.

  104. Change From Baseline in EQ-5D-VAS Score at Cycle 37 [ Time Frame: 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.

  105. Change From Baseline in EQ-5D-VAS Score at Cycle 39 [ Time Frame: 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.

  106. Change From Baseline in EQ-5D-VAS Score at Cycle 40 [ Time Frame: 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.

  107. Change From Baseline in EQ-5D-VAS Score at Cycle 42 [ Time Frame: 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.

  108. Change From Baseline in EQ-5D-VAS Score at Cycle 44 [ Time Frame: 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.

  109. Change From Baseline in EQ-5D-VAS Score at Cycle 46 [ Time Frame: 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.

  110. Change From Baseline in EQ-5D-VAS Score at End of Study [ Time Frame: 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.


Secondary Outcome Measures :
  1. Percentage of Participants Who Died Due to Any Cause [ Time Frame: Baseline up to death (overall approximately 5 years and 9 months) ]
  2. Overall Survival [ Time Frame: 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.

  3. Percentage of Participants With Disease Progression [ Time Frame: 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.

  4. Time to Disease Progression [ Time Frame: 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.

  5. Percentage of Participants By Karnofsky Performance Status Scale Scores [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094184


Locations
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United Kingdom
Bangor, United Kingdom, LL57 2PD
Cottingham, United Kingdom, HU16 5JG
Exeter, United Kingdom, EX2 5DW
Grimsby, United Kingdom, DN33 2BA
Harrogate, United Kingdom, HG2 8AY
Plymouth, United Kingdom, PL6 8DH
Portsmouth, United Kingdom, PO6 3LY
Preston, United Kingdom, PR2 9HT
Somerset, United Kingdom, TA1 5DA
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01094184    
Other Study ID Numbers: ML22780
2009-014279-37
First Posted: March 26, 2010    Key Record Dates
Results First Posted: March 22, 2018
Last Update Posted: March 22, 2018
Last Verified: August 2017
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Docetaxel
Bevacizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors