A Study of Avastin (Bevacizumab) + Xeloda (Capecitabine)as Maintenance Therapy in Patients With HER2-Negative Metastatic Breast Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT00929240
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab [Avastin] — DRUG
    15 mg/kg iv on day 1 of each 3 week cycle (maintenance phase)
  • capecitabine [Xeloda] — DRUG
    1000 mg/m2 po bid on days 1-14 of each 3 week cycle (maintenance phase)

Study Details

This randomized study will compare maintenance therapy with Avastin (bevacizumab) + Xeloda (capecitabine) versus Avastin alone, in patients with HER2-negative metastatic breast cancer who have not progressed during first-line therapy with docetaxel + Avastin. Eligible patients will receive up to 6 x 3 week cycles of treatment with Avastin (15 mg/mg IV on Day 1 of each cycle) + docetaxel (75-100 mg/m2 IV on Day 1 of each cycle). Those patients who do not progress will be randomized to 3 week cycles of either a) Avastin (15 mg/kg IV on Day 1 of each cycle) + Xeloda (1000 mg/m2 po bid on Days 1-14 of each cycle) or b) Avastin alone. Study treatment will continue until disease progression, unacceptable toxicity, patient request for withdrawal or end of study, and the target sample size is 100-500 individuals.

Key Dates

First listed
Jun 26, 2009
Start date
Jul 31, 2009
Status verified
Mar 2015
Primary completion
Jun 30, 2014
Completion
Jun 30, 2014

Study Design

Enrollment
287 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Avastin (bevacizumab)
  • Experimental: Avastin (bevacizumab) + Xeloda (capecitabine)

Primary Outcome Measure

Percentage of Participants With Disease Progression or Death (Maintenance Phase Data Cutoff October 4, 2013) [ Time Frame: Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years ]

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