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

Sponsor
Hoffmann-La Roche
Study ID
NCT01094184
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
  • Paclitaxel — DRUG
    Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.
  • Docetaxel — DRUG
    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.

Study Details

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.

Key Dates

First listed
Mar 26, 2010
Start date
Mar 31, 2010
Status verified
Aug 2017
Primary completion
Dec 31, 2015
Completion
Dec 31, 2015

Study Design

Enrollment
49 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

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) ]

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