A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer

Roche

Status and phase: Completed; Phase 4

Conditions: Breast Cancer

Treatments: Drug: Capecitabine; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00121836

ML18527

Details and patient eligibility

About

This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg intravenously (IV) on Day 1 of each 3-week cycle. The anticipated time on study treatment was until disease progression or unacceptable toxicity. The target sample size was <100 individuals.

Enrollment: 109 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women >=18 years of age
• HER2-negative metastatic breast cancer
• Previous adjuvant chemotherapy or hormonal treatment
• >=1 measurable target lesion

Exclusion criteria

• Previous treatment with chemotherapy, an anti-angiogenic agent, or a biologic therapy for advanced or metastatic cancer
• Radiation therapy within 4 weeks of study treatment start or insufficient recovery from the effects of prior radiation therapy
• Central nervous system metastases
• Other malignancy within last 5 years, except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix
• Serious concurrent infection

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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109 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Bevacizumab

Drug: Capecitabine