A Study of Avastin (Bevacizumab) + Xeloda (Capecitabine)as Maintenance Therapy in Patients With HER2-Negative Metastatic Breast Cancer

Roche

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00929240

2008-006872-31

MO22223

Details and patient eligibility

About

This randomized study will compare maintenance therapy with Avastin (bevacizumab) + Xeloda (capecitabine) versus Avastin alone, in patients with HER2-negative metastatic breast cancer who have not progressed during first-line therapy with docetaxel + Avastin. Eligible patients will receive up to 6 x 3 week cycles of treatment with Avastin (15 mg/mg IV on Day 1 of each cycle) + docetaxel (75-100 mg/m2 IV on Day 1 of each cycle). Those patients who do not progress will be randomized to 3 week cycles of either a) Avastin (15 mg/kg IV on Day 1 of each cycle) + Xeloda (1000 mg/m2 po bid on Days 1-14 of each cycle) or b) Avastin alone. Study treatment will continue until disease progression, unacceptable toxicity, patient request for withdrawal or end of study, and the target sample size is 100-500 individuals.

Enrollment: 287 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• HER2-negative metastatic breast cancer
• candidates for taxane-based chemotherapy;
• ECOG performance status of 0 or 1.

Exclusion criteria

• previous chemotherapy for metastatic breast cancer;
• prior adjuvant/neo-adjuvant chemotherapy within 6 months prior to study;
• prior radiotherapy for treatment of metastatic disease;
• chronic daily treatment with aspirin (325 mg/day) or clopidogrel(>75mg/day).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

287 participants in 2 patient groups

Avastin (bevacizumab)

Active Comparator group

Treatment:

Drug: bevacizumab [Avastin]

Avastin (bevacizumab) + Xeloda (capecitabine)

Experimental group

Treatment:

Drug: capecitabine [Xeloda]

Drug: bevacizumab [Avastin]