A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Primary Breast Cancer

Roche

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02005549

ML19869

Details and patient eligibility

About

This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel and Xeloda, given as pre-operative therapy to patients with primary breast cancer. Avastin will be administered every 3 weeks, for the first 5 cycles of chemotherapy. The anticipated time on study treatment is 3-12 months.

Enrollment: 18 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female patients, 18-70years of age;
• histologically-proven invasive breast cancer;
• no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix;
• no distant disease/secondary cancer.

Exclusion criteria

• pregnant or lactating women;
• pre-operative local treatment for breast cancer;
• prior or concurrent systemic antitumor therapy;
• clinically significant cardiac disease.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Neoadjuvant Therapy

Experimental group

Treatment:

Drug: bevacizumab [Avastin]

Drug: capecitabine [Xeloda]

Drug: docetaxel