A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel, versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or metastatic breast cancer who have not received prior chemotherapy for their metastatic disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) + Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Bevacizumab; Docetaxel; Trastuzumab

Criteria

Inclusion Criteria:

• adult patients, >=18 years of age;

• HER2 positive breast cancer with locally recurrent or metastatic lesions;

• eligible for chemotherapy;

• baseline LVEF >=50%.

Exclusion Criteria:

• previous chemotherapy for metastatic or locally recurrent breast cancer;

• previous radiotherapy for metastatic breast cancer (except for metastatic bone pain relief);

• other primary tumor within last 5 years, with the exception of basal or squamous skin cancer, or in situ cancer of the cervix;

• clinically significant cardiovascular disease;

• chronic daily treatment with aspirin (>325mg/day) or clopidogrel (>75mg/day).