At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed breast cancer with locally advanced and/or metastatic disease
- ✓0-1 prior lines of chemotherapy for metastatic disease
- ✓May have received prior neo-adjuvant or adjuvant taxane if ≥6 months since completion
- ✓Measurable or non-measurable (evaluable) disease required
- ✕Parenchymal or leptomeningeal brain metastases
- ✕Second primary malignancy (except in situ cervical or adequately treated nonmelanomatous skin cancer, or other malignancy treated ≥5 years prior with no recurrence)
- ✕Peripheral neuropathy ≥grade 2
- ✕Prior treatment with gemcitabine or capecitabine
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Trial of Gemcitabine Plus Docetaxel vs. Docetaxel Plus Capecitabine in Metastatic Breast Cancer in 1st and 2nd
In Brief
A Phase 3 clinical trial evaluating gemcitabine, docetaxel, and 1 other intervention for Breast Cancer and 2 related conditions. Completed, enrolled 475 participants across 65 sites in 8 countries.
Detailed Summary
This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/ capecitabine doublets, with crossover to the alternate agent. The experimental arm will receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75 mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1 through 14 repeated every three weeks. Patients who progress on the experimental arm, will be treated with capecitabine as dosed on the comparator arm. Patients who progress on the comparator arm will be treated with gemcitabine as dosed on the experimental arm.
Study Details
Timeline
Interventions
1000 mg/m2, intravenous (IV) day 1 and day 8 every 21 days until disease progression
75 mg/m2, intravenous (IV), every 21 days until disease progression
1000 mg/m2, by mouth (PO) twice a day (BID), days 1-14, every 21 days until disease progression