A Study of Avastin (Bevacizumab) Plus Herceptin (Trastuzumab) in Patients With Primary Inflammatory HER2-Positive Breast Cancer.

Roche

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: trastuzumab [Herceptin]; Drug: bevacizumab [Avastin]; Drug: Standard chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00717405

ML21531

2008-000783-16

Details and patient eligibility

About

This single arm study will assess the efficacy and safety of preoperative treatment with Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of pre-operative chemotherapy + Avastin + Herceptin. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Enrollment: 52 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult females, >=18 years of age;
• inflammatory breast cancer;
• HER2-positive tumors;
• performance status 0-2.

Exclusion criteria

• metastases;
• previous treatment with chemotherapy, radiation therapy or hormone therapy for a breast tumor;
• clinically significant cardiovascular disease, or history of thrombotic disorders.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

1

Experimental group

Treatment:

Drug: trastuzumab [Herceptin]

Drug: bevacizumab [Avastin]

Drug: Standard chemotherapy