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
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer
Both
Breast Cancer
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Best overall response (% of patients with complete or partial response)
Outcome Time Frame:
Event driven;assessments made every 9-12 weeks
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Russia: Ministry of Health of the Russian Federation
Study ID:
MO21926
NCT ID:
NCT00811135
Start Date:
December 2008
Completion Date:
March 2013
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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