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Withdrawn
Trial end date:
2013-08-01
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
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