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

Roche

Status and phase: Withdrawn; Phase 2

Conditions: Breast Cancer

Treatments: Drug: capecitabine [Xeloda]; Drug: docetaxel; Drug: bevacizumab [Avastin]; Drug: trastuzumab [Herceptin]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00964704

ML22056

2008-007495-20

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Drug: capecitabine [Xeloda]

Drug: trastuzumab [Herceptin]

Drug: docetaxel

Drug: bevacizumab [Avastin]