Overview
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
Status:
Withdrawn
Withdrawn
Trial end date:
2013-08-01
2013-08-01
Target enrollment:
0
0
Participant gender:
All
All
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 breast cancer after early relapse on adjuvant Herceptin therapy. Patients will receive Herceptin at a loading dose of 8mg/kg iv followed by 6mg/kg iv every three weeks, and Avastin 15mg/kg every 3 weeks. At first sign of disease progression Xeloda 1000mg/m2 bid po will be added on days 1-14 of each cycle, or docetaxel (100mg/m2 iv every 3 weeks) if Xeloda is not indicated for a patient. Anticipated time on study treatment is until disease-progression on second line treatment and target sample size is <100.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hoffmann-La RocheTreatments:
Bevacizumab
Capecitabine
Docetaxel
Trastuzumab
Criteria
Inclusion Criteria:- 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 Criteria:
- 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