This trial is active, not recruiting.

Condition breast cancer
Treatments bevacizumab [avastin], capecitabine [xeloda], trastuzumab [herceptin]
Phase phase 2
Sponsor Hoffmann-La Roche
Start date December 2008
End date December 2015
Trial size 88 participants
Trial identifier NCT00811135, 2008-003283-20, MO21926


This single arm study will assess the efficacy and safety of Avastin in combination with Herceptin and Xeloda as first-line treatment of patients with HER2-positive locally recurrent or metastatic breast cancer. Patients will receive 3-weekly treatment cycles of Herceptin (8mg/kg iv on day 1 of first cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles), Xeloda (1000mg/m2 bid po on days 1-14 of each treatment cycle) and Avastin (15mg/kg on day 2 of first treatment cycle,and on day 1 of each subsequent cycle).The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
bevacizumab [avastin]
15mg/kg iv on day 2 of first 3-week cycle,and on day 1 of subsequent cycles
capecitabine [xeloda]
1000mg/m2 bid po on days 1-14 of each 3-week cycle
trastuzumab [herceptin]
8mg/kg iv loading dose on day 1 of first 3-week cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles

Primary Outcomes

Best overall response (% of patients with complete or partial response)
time frame: Event driven;assessments made every 9-12 weeks

Secondary Outcomes

Progression free survival, overall survival, duration of response
time frame: Event driven;assessments made every 9-12 weeks
Adverse events, cardiac events, laboratory tests
time frame: Throughout study;assessments made every 3 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - adult patients, >=18 years of age; - breast cancer with measurable locally recurrent or metastatic lesions; - candidate for chemotherapy; - HER2-positive disease; - ECOG PS of <=2. Exclusion Criteria: - previous anticancer therapy for metastatic breast cancer; - previous radiotherapy for metastatic breast cancer (except for adjuvant radiotherapy >=6 months before enrollment); - chronic daily treatment with corticosteroids (>=10mg/day), aspirin (>325 mg/day) or clopidogrel (>75mg/day); - other primary tumor within last 5 years, except for adequately treated cervical cancer in situ, squamous or basal cell skin cancer; - uncontrolled hypertension or significant cardiovascular disease.

Additional Information

Official title A Single Arm Open-label, Phase II Study of Bevacizumab in Combination With Trastuzumab and Capecitabine as First-line Treatment of Patients With HER2-positive Locally Recurrent or Metastatic Breast Cancer
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.