A Study of Bevacizumab in Combination With Gemcitabine and Carboplatin in Participants With Triple Negative Metastatic Breast Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT01201265
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    15 mg/kg iv every 3 weeks
  • Carboplatin — DRUG
    to an AUC = 2, on days 1 and 8 of each 3-week cycle
  • Gemcitabine — DRUG
    1000 mg/m2 iv on days 1 and 8 of each 3-week cycle

Study Details

This multicenter study will assess the efficacy and safety of bevacizumab in combination with gemcitabine and cisplatin as first line treatment in participants with triple negative metastatic breast cancer. Participants will receive bevacizumab at a dose of 15 mg/kg intravenously (iv) every 3 weeks, plus gemcitabine (1000 mg/m2 iv) and carboplatin (iv to an area under curve \[AUC\]=2) on Days 1 and 8 of each 3-week cycle. Anticipated time on study treatment is until disease progression.

Key Dates

First listed
Sep 14, 2010
Start date
Feb 28, 2011
Status verified
Apr 2016
Primary completion
Apr 30, 2015
Completion
Apr 30, 2015

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Overall Participants
    Participants received a combination therapy of bevacizumab with gemcitabine plus carboplatin.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: From the date of registration until the disease progression or death (up to 1541 days). ]

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