Status:
WITHDRAWN
A Study of Herceptin (Trastuzumab) in Combination With Avastin (Bevacizumab) and Sequential Xeloda (Capecitabine) or Docetaxel in Patients With HER2-Positive Locally Recurrent or Metastatic Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This single arm, open-label study will evaluate the safety and efficacy of Herceptin in combination with Avastin and sequential Xeloda in patients with locally recurrent or metastatic HER2-positive br...
Eligibility Criteria
Inclusion
- male or female patients, age \>/=18 years
- locally recurrent or metastatic HER2-positive breast cancer
- disease progression during or up to 12 months after prior adjuvant therapy with trastuzumab
- LVEF \>/=55% at baseline
Exclusion
- prior treatment with bevacizumab or capecitabine
- anthracyclines in prior adjuvant or neoadjuvant treatment exceeding cumulative dose of 360mg/m2 for doxorubicin and 720mg/kg for epirubicin
- chronic daily treatment with corticosteroids (\>10mg/day methylprednisolone equivalent; excluding inhaled corticosteroids), or aspirin (\>325mg/day), or clopidogrel (\>75mg/day)
- clinically significant cardiac disease, or cardiac toxicity during previous trastuzumab therapy
- evidence of spinal cord compression or CNS metastasis
- history of other malignancy, unless disease-free for \>/=5 years or treated curatively for carcinoma in situ of the cervix or non-melanomatous skin cancer
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00964704
Start Date
March 1 2011
End Date
August 1 2013
Last Update
November 2 2016
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