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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Bevacizumab

Paclitaxel

Docetaxel

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Bevacizumab 10 mg/kg Q2W

Bevacizumab 15 mg/kg Q3W

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2

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.

Change From Baseline in FACT-B Score at Cycle 3

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.

Change From Baseline in FACT-B Score at Cycle 4

Change From Baseline in FACT-B Score at Cycle 5

Change From Baseline in FACT-B Score at Cycle 6

Change From Baseline in FACT-B Score at Cycle 7

Change From Baseline in FACT-B Score at Cycle 8

Change From Baseline in FACT-B Score At Cycle 9

Change From Baseline in FACT-B Score at Cycle 10

Change From Baseline in FACT-B Score at Cycle 11

Change From Baseline in FACT-B Score at Cycle 12

Change From Baseline in FACT-B Score at Cycle 13

Change From Baseline in FACT-B Score at Cycle 14

Change From Baseline in FACT-B Score at Cycle 15

Change From Baseline in FACT-B Score at Cycle 16

Change From Baseline in FACT-B Score at Cycle 17

Change From Baseline in FACT-B Score at Cycle 18

Change From Baseline in FACT-B Score at Cycle 20

Change From Baseline in FACT-B Score at Cycle 21

Change From Baseline in FACT-B Score at Cycle 22

Change From Baseline in FACT-B Score at Cycle 23

Change From Baseline in FACT-B Score at Cycle 24

Change From Baseline in FACT-B Score at Cycle 25

Change From Baseline in FACT-B Score at Cycle 26

Change From Baseline in FACT-B Score at Cycle 27

Change From Baseline in FACT-B Score at Cycle 28

Change From Baseline in FACT-B Score at Cycle 29

Change From Baseline in FACT-B Score at Cycle 30

Change From Baseline in FACT-B Score at Cycle 32

Change From Baseline in FACT-B Score at Cycle 36

Change From Baseline in FACT-B Score at Cycle 37

Change From Baseline in FACT-B Score at Cycle 39

Change From Baseline in FACT-B Score at Cycle 42

Change From Baseline in FACT-B Score at Cycle 44

Change From Baseline in FACT-B Score at Cycle 46

Change From Baseline in FACT-B Score at End of Study

Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2

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.

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 3

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 7

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 9

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 11

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 13

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 15

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 16

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 17

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 20

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 22

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 24

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 25

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 28

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 32

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 37

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 39

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 40

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 42

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 44

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 46

Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study

Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2

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.

Change From Baseline in EQ-5D-VAS Score at Cycle 3

Change From Baseline in EQ-5D-VAS Score at Cycle 4

Change From Baseline in EQ-5D-VAS Score at Cycle 5

Change From Baseline in EQ-5D-VAS Score at Cycle 6

Change From Baseline in EQ-5D-VAS Score at Cycle 7

Change From Baseline in EQ-5D-VAS Score at Cycle 8

Change From Baseline in EQ-5D-VAS Score at Cycle 9

Change From Baseline in EQ-5D-VAS Score at Cycle 10

Change From Baseline in EQ-5D-VAS Score at Cycle 11

Change From Baseline in EQ-5D-VAS Score at Cycle 12

Change From Baseline in EQ-5D-VAS Score at Cycle 13

Change From Baseline in EQ-5D-VAS Score at Cycle 14

Change From Baseline in EQ-5D-VAS Score at Cycle 15

Change From Baseline in EQ-5D-VAS Score at Cycle 16

Change From Baseline in EQ-5D-VAS Score at Cycle 17

Change From Baseline in EQ-5D-VAS Score at Cycle 18

Change From Baseline in EQ-5D-VAS Score at Cycle 20

Change From Baseline in EQ-5D-VAS Score at Cycle 21

Change From Baseline in EQ-5D-VAS Score at Cycle 22

Change From Baseline in EQ-5D-VAS Score at Cycle 23

Change From Baseline in EQ-5D-VAS Score at Cycle 24

Change From Baseline in EQ-5D-VAS Score at Cycle 25

Change From Baseline in EQ-5D-VAS Score at Cycle 26

Change From Baseline in EQ-5D-VAS Score at Cycle 27

Change From Baseline in EQ-5D-VAS Score at Cycle 28

Change From Baseline in EQ-5D-VAS Score at Cycle 29

Change From Baseline in EQ-5D-VAS Score at Cycle 30

Change From Baseline in EQ-5D-VAS Score at Cycle 32

Change From Baseline in EQ-5D-VAS Score at Cycle 36

Change From Baseline in EQ-5D-VAS Score at Cycle 37

Change From Baseline in EQ-5D-VAS Score at Cycle 39

Change From Baseline in EQ-5D-VAS Score at Cycle 40

Change From Baseline in EQ-5D-VAS Score at Cycle 42

Change From Baseline in EQ-5D-VAS Score at Cycle 44

Change From Baseline in EQ-5D-VAS Score at Cycle 46

Change From Baseline in EQ-5D-VAS Score at End of Study

Secondary Outcome Measures

Percentage of Participants Who Died Due to Any Cause

Overall Survival

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.

Percentage of Participants With Disease Progression

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.

Time to Disease Progression

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.

Percentage of Participants By Karnofsky Performance Status Scale Scores

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.

Full Information

NCT ID

NCT01094184

First Posted

March 16, 2010

Last Updated

August 25, 2017

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01094184

Brief Title

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

Acronym

BATMAN

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 Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bevacizumab 10 mg/kg Q2W

Arm Type

Experimental

Arm Description

Arm Title

Bevacizumab 15 mg/kg Q3W

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2

Description

Time Frame

Baseline, Cycle 2 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 3

Description

Time Frame

Baseline, Cycle 3 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 4

Description

Time Frame

Baseline, Cycle 4 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 5

Description

Time Frame

Baseline, Cycle 5 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 6

Description

Time Frame

Baseline, Cycle 6 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 7

Description

Time Frame

Baseline, Cycle 7 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 8

Description

Time Frame

Baseline, Cycle 8 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score At Cycle 9

Description

Time Frame

Baseline, Cycle 9 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 10

Description

Time Frame

Baseline, Cycle 10 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 11

Description

Time Frame

Baseline, Cycle 11 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 12

Description

Time Frame

Baseline, Cycle 12 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 13

Description

Time Frame

Baseline, Cycle 13 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 14

Description

Time Frame

Baseline, Cycle 14 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 15

Description

Time Frame

Baseline, Cycle 15 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 16

Description

Time Frame

Baseline, Cycle 16 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 17

Description

Time Frame

Baseline, Cycle 17 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 18

Description

Time Frame

Baseline, Cycle 18 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 20

Description

Time Frame

Baseline, Cycle 20 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 21

Description

Time Frame

Baseline, Cycle 21 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 22

Description

Time Frame

Baseline, Cycle 22 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 23

Description

Time Frame

Baseline, Cycle 23 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 24

Description

Time Frame

Baseline, Cycle 24 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 25

Description

Time Frame

Baseline, Cycle 25 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 26

Description

Time Frame

Baseline, Cycle 26 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 27

Description

Time Frame

Baseline, Cycle 27 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 28

Description

Time Frame

Baseline, Cycle 28 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 29

Description

Time Frame

Baseline, Cycle 29 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 30

Description

Time Frame

Baseline, Cycle 30 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 32

Description

Time Frame

Baseline, Cycle 32 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 36

Description

Time Frame

Baseline, Cycle 36 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 37

Description

Time Frame

Baseline, Cycle 37 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 39

Description

Time Frame

Baseline, Cycle 39 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 42

Description

Time Frame

Baseline, Cycle 42 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 44

Description

Time Frame

Baseline, Cycle 44 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at Cycle 46

Description

Time Frame

Baseline, Cycle 46 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in FACT-B Score at End of Study

Description

Time Frame

Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)

Title

Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2

Description

Time Frame

Baseline, Cycle 2 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 3

Description

Time Frame

Baseline, Cycle 3 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4

Description

Time Frame

Baseline, Cycle 4 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5

Description

Time Frame

Baseline, Cycle 5 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6

Description

Time Frame

Baseline, Cycle 6 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 7

Description

Time Frame

Baseline, Cycle 7 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8

Description

Time Frame

Baseline, Cycle 8 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 9

Description

Time Frame

Baseline, Cycle 9 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10

Description

Time Frame

Baseline, Cycle 10 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 11

Description

Time Frame

Baseline, Cycle 11 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12

Description

Time Frame

Baseline, Cycle 12 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 13

Description

Time Frame

Baseline, Cycle 13 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14

Description

Time Frame

Baseline, Cycle 14 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 15

Description

Time Frame

Baseline, Cycle 15 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 16

Description

Time Frame

Baseline, Cycle 16 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 17

Description

Time Frame

Baseline, Cycle 17 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18

Description

Time Frame

Baseline, Cycle 18 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 20

Description

Time Frame

Baseline, Cycle 20 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21

Description

Time Frame

Baseline, Cycle 21 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 22

Description

Time Frame

Baseline, Cycle 22 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23

Description

Time Frame

Baseline, Cycle 23 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 24

Description

Time Frame

Baseline, Cycle 24 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 25

Description

Time Frame

Baseline, Cycle 25 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26

Description

Time Frame

Baseline, Cycle 26 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27

Description

Time Frame

Baseline, Cycle 27 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 28

Description

Time Frame

Baseline, Cycle 28 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29

Description

Time Frame

Baseline, Cycle 29 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30

Description

Time Frame

Baseline, Cycle 30 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 32

Description

Time Frame

Baseline, Cycle 32 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36

Description

Time Frame

Baseline, Cycle 36 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 37

Description

Time Frame

Baseline, Cycle 37 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 39

Description

Time Frame

Baseline, Cycle 39 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 40

Description

Time Frame

Baseline, Cycle 40 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 42

Description

Time Frame

Baseline, Cycle 42 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 44

Description

Time Frame

Baseline, Cycle 44 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 46

Description

Time Frame

Baseline, Cycle 46 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study

Description

Time Frame

Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)

Title

Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2

Description

Time Frame

Baseline, Cycle 2 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 3

Description

Time Frame

Baseline, Cycle 3 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 4

Description

Time Frame

Baseline, Cycle 4 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 5

Description

Time Frame

Baseline, Cycle 5 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 6

Description

Time Frame

Baseline, Cycle 6 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 7

Description

Time Frame

Baseline, Cycle 7 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 8

Description

Time Frame

Baseline, Cycle 8 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 9

Description

Time Frame

Baseline, Cycle 9 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 10

Description

Time Frame

Baseline, Cycle 10 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 11

Description

Time Frame

Baseline, Cycle 11 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 12

Description

Time Frame

Baseline, Cycle 12 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 13

Description

Time Frame

Baseline, Cycle 13 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 14

Description

Time Frame

Baseline, Cycle 14 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 15

Description

Time Frame

Baseline, Cycle 15 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 16

Description

Time Frame

Baseline, Cycle 16 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 17

Description

Time Frame

Baseline, Cycle 17 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 18

Description

Time Frame

Baseline, Cycle 18 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 20

Description

Time Frame

Baseline, Cycle 20 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 21

Description

Time Frame

Baseline, Cycle 21 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 22

Description

Time Frame

Baseline, Cycle 22 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 23

Description

Time Frame

Baseline, Cycle 23 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 24

Description

Time Frame

Baseline, Cycle 24 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 25

Description

Time Frame

Baseline, Cycle 25 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 26

Description

Time Frame

Baseline, Cycle 26 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 27

Description

Time Frame

Baseline, Cycle 27 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 28

Description

Time Frame

Baseline, Cycle 28 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 29

Description

Time Frame

Baseline, Cycle 29 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 30

Description

Time Frame

Baseline, Cycle 30 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 32

Description

Time Frame

Baseline, Cycle 32 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 36

Description

Time Frame

Baseline, Cycle 36 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 37

Description

Time Frame

Baseline, Cycle 37 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 39

Description

Time Frame

Baseline, Cycle 39 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 40

Description

Time Frame

Baseline, Cycle 40 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 42

Description

Time Frame

Baseline, Cycle 42 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 44

Description

Time Frame

Baseline, Cycle 44 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at Cycle 46

Description

Time Frame

Baseline, Cycle 46 (Cycle length=2 and 3 weeks)

Title

Change From Baseline in EQ-5D-VAS Score at End of Study

Description

Time Frame

Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)

Secondary Outcome Measure Information:

Title

Percentage of Participants Who Died Due to Any Cause

Time Frame

Baseline up to death (overall approximately 5 years and 9 months)

Title

Overall Survival

Description

Time Frame

Baseline up to death (overall approximately 5 years and 9 months)

Title

Percentage of Participants With Disease Progression

Description

Time Frame

Baseline up to disease progression (overall approximately 5 years and 9 months)

Title

Time to Disease Progression

Description

Time Frame

Baseline up to disease progression (overall approximately 5 years and 9 months)

Title

Percentage of Participants By Karnofsky Performance Status Scale Scores

Description

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)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

Bangor

ZIP/Postal Code

LL57 2PD

Country

United Kingdom

City

Cottingham

ZIP/Postal Code

HU16 5JG

Country

United Kingdom

City

Exeter

ZIP/Postal Code

EX2 5DW

Country

United Kingdom

City

Grimsby

ZIP/Postal Code

DN33 2BA

Country

United Kingdom

City

Harrogate

ZIP/Postal Code

HG2 8AY

Country

United Kingdom

City

Plymouth

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

City

Portsmouth

ZIP/Postal Code

PO6 3LY

Country

United Kingdom

City

Preston

ZIP/Postal Code

PR2 9HT

Country

United Kingdom

City

Somerset

ZIP/Postal Code

TA1 5DA

Country

United Kingdom

City

Wolverhampton

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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