Clinical trial NCT01094184: A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-03-26
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2
timeFrame: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 3
timeFrame: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 4
timeFrame: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 5
timeFrame: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 6
timeFrame: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 7
timeFrame: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 8
timeFrame: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score At Cycle 9
timeFrame: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 10
timeFrame: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 11
timeFrame: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 12
timeFrame: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 13
timeFrame: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 14
timeFrame: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 15
timeFrame: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 16
timeFrame: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 17
timeFrame: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 18
timeFrame: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 20
timeFrame: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 21
timeFrame: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 22
timeFrame: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 23
timeFrame: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 24
timeFrame: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 25
timeFrame: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 26
timeFrame: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 27
timeFrame: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 28
timeFrame: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 29
timeFrame: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 30
timeFrame: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 32
timeFrame: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 36
timeFrame: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 37
timeFrame: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 39
timeFrame: Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 42
timeFrame: Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 44
timeFrame: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at Cycle 46
timeFrame: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in FACT-B Score at End of Study
timeFrame: Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
measure: Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2
timeFrame: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 3
timeFrame: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4
timeFrame: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5
timeFrame: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6
timeFrame: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 7
timeFrame: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8
timeFrame: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 9
timeFrame: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10
timeFrame: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 11
timeFrame: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12
timeFrame: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 13
timeFrame: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14
timeFrame: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 15
timeFrame: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 16
timeFrame: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 17
timeFrame: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18
timeFrame: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 20
timeFrame: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21
timeFrame: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 22
timeFrame: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23
timeFrame: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 24
timeFrame: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 25
timeFrame: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26
timeFrame: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27
timeFrame: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 28
timeFrame: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29
timeFrame: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30
timeFrame: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 32
timeFrame: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36
timeFrame: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 37
timeFrame: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 39
timeFrame: Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 40
timeFrame: Baseline, Cycle 40 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 42
timeFrame: Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 44
timeFrame: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 46
timeFrame: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study
timeFrame: Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
measure: Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2
timeFrame: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 3
timeFrame: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 4
timeFrame: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 5
timeFrame: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 6
timeFrame: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 7
timeFrame: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 8
timeFrame: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 9
timeFrame: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 10
timeFrame: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 11
timeFrame: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 12
timeFrame: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 13
timeFrame: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 14
timeFrame: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 15
timeFrame: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 16
timeFrame: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 17
timeFrame: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 18
timeFrame: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 20
timeFrame: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 21
timeFrame: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 22
timeFrame: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 23
timeFrame: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 24
timeFrame: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 25
timeFrame: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 26
timeFrame: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 27
timeFrame: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 28
timeFrame: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 29
timeFrame: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 30
timeFrame: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 32
timeFrame: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 36
timeFrame: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 37
timeFrame: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 39
timeFrame: Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 40
timeFrame: Baseline, Cycle 40 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 42
timeFrame: Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 44
timeFrame: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at Cycle 46
timeFrame: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
measure: Change From Baseline in EQ-5D-VAS Score at End of Study
timeFrame: Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
Secondary outcomes:
measure: Percentage of Participants Who Died Due to Any Cause
timeFrame: Baseline up to death (overall approximately 5 years and 9 months)
measure: Overall Survival
timeFrame: Baseline up to death (overall approximately 5 years and 9 months)
measure: Percentage of Participants With Disease Progression
timeFrame: Baseline up to disease progression (overall approximately 5 years and 9 months)
measure: Time to Disease Progression
timeFrame: Baseline up to disease progression (overall approximately 5 years and 9 months)
measure: Percentage of Participants By Karnofsky Performance Status Scale Scores
timeFrame: 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)
Other outcomes:
Locations:
city: Bangor
country: United Kingdom
city: Cottingham
country: United Kingdom
city: Exeter
country: United Kingdom
city: Grimsby
country: United Kingdom
city: Harrogate
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Portsmouth
country: United Kingdom
city: Preston
country: United Kingdom
city: Somerset
country: United Kingdom
city: Wolverhampton
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: