At a glance
ClinicalIndex Comparison Record- ✓Female patients with histologically or cytologically confirmed breast cancer
- ✓Stage IV (metastatic) disease
- ✓ECOG performance status 0 or 1
- ✓Prior anthracycline exposure (adjuvant or neoadjuvant) followed by progression to metastatic disease
- ✕Prior chemotherapy for metastatic disease
- ✕Brain metastases (known or suspected)
- ✕Peripheral neuropathy Grade >1 (CTC)
- ✕Concurrent tumor therapy including chemotherapy, hormonal therapy, or immunotherapy (including trastuzumab)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Phase II Study of Biweekly Gemcitabine-Paclitaxel, Biweekly Gemcitabine-Carboplatin and Biweekly Gemcitabine-Cisplatin as First-Line Treatment in Metastatic Breast Cancer After Anthracycline Failure
In Brief
A Phase 2 clinical trial evaluating gemcitabine, paclitaxel, and 2 other interventions for Breast Cancer. Completed, enrolled 147 participants across 18 sites in 6 countries.
Detailed Summary
The gemcitabine-paclitaxel and gemcitabine-platinum combinations have shown promise in the treatments of MBC; however, the optimal dosing schedules for these combinations have not yet been determined. The primary objective of this study is to compare the response rates of the gemcitabine-paclitaxel, gemcitabine-carboplatin, and gemcitabine-cisplatin combinations when administered on a biweekly schedule in metastatic breast cancer.
Study Details
Timeline
Interventions
2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles
150 mg/m2, IV, every 14 days x 8 cycles
Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles
50 mg/m2, IV, every 14 days x 8 cycles