At a glance
ClinicalIndex Comparison Record- ✓Locally advanced or metastatic breast cancer
- ✓Prior anthracycline therapy in neoadjuvant or adjuvant setting
- ✓At least 12-month disease-free interval since last cytotoxic therapy
- ✓No more than 1 prior cytotoxic chemotherapy regimen for advanced disease (anthracyclines, taxanes, or antitubulin agents not permitted)
- ✕More than 1 prior cytotoxic chemotherapy regimen for advanced breast cancer
- ✕Prior treatment of advanced breast cancer with anthracycline, paclitaxel, docetaxel, vinorelbine, or vinblastine
- ✕Less than 2 months since last trastuzumab dose
- ✕Less than 3 weeks since tamoxifen/fulvestrant or less than 1 week since other hormonal therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Controlled Study of Docetaxel Monotherapy or Docetaxel and DOXIL for the Treatment of Advanced Breast Cancer
In Brief
A Phase 3 clinical trial evaluating Docetaxel and DOXIL for Breast Cancer. Completed, enrolled 751 participants across 147 sites in 18 countries.
Detailed Summary
The purpose of the study is to evaluate whether the time to progression for the DOXIL and docetaxel combination therapy group was superior to that of the group treated with docetaxel monotherapy in participants with advanced breast cancer.
Study Details
Timeline
Interventions
Docetaxel monotherapy: docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. DOXIL in combination with docetaxel: docetaxel 60 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle
DOXIL 30 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.