At a glance
ClinicalIndex Comparison Record- ✓Women aged ≥18 years
- ✓HER2-negative metastatic breast cancer
- ✓Prior adjuvant chemotherapy or hormonal treatment for early-stage disease
- ✓At least 1 measurable target lesion by imaging
- ✕Prior chemotherapy, anti-angiogenic agent, or biologic therapy for advanced/metastatic disease
- ✕Radiation therapy within 4 weeks of study start or insufficient recovery from prior radiation
- ✕Central nervous system metastases
- ✕Other active malignancy within 5 years (except skin basal cell carcinoma or cervical carcinoma in situ)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Study of Xeloda Plus Avastin at Time of Disease Progression in Treatment-naïve Women With HER2-negative Metastatic Breast Cancer
In Brief
A Phase 4 clinical trial evaluating Capecitabine and Bevacizumab for Breast Cancer. Completed, enrolled 109 participants across 57 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
1000 mg/m² PO BID on Days 1-15 of each 3-week cycle
15 mg IV on Day 1 of each 3-week cycle