At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed invasive, non-inflammatory breast carcinoma
- ✓Stage II-III disease or high-risk stage I (Ki67 >35%, poorly differentiated, ER/PR negative, or lymphovascular invasion)
- ✓pN2a or pN3a nodal disease eligible; infraclavicular involvement excluded
- ✓Adequate bone marrow: ANC >1500/mm3, platelets >100,000/mm3
- ✕Inflammatory breast cancer, metastatic disease, or clinical N2/N3 nodal disease
- ✕pN2b disease (clinically apparent internal mammary node involvement without axillary involvement)
- ✕T4 lesions in neoadjuvant setting; limited T4 eligible in adjuvant setting only
- ✕Severe hypersensitivity to cremophor or polysorbate 80
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer
In Brief
A Phase 1 clinical trial evaluating Paclitaxel, Docetaxel, and 1 other intervention for Breast Cancer. Completed, enrolled 603 participants across 1 site.
Detailed Summary
Primary Objectives: * Determine the impact of each regimen on the disease free and overall survival of patients with operable breast cancer. * Determine the ability of docetaxel/capecitabine to downstage primary breast cancer when administered in the neoadjuvant setting when compared with weekly paclitaxel. * Determine the ability of each regimen to enhance breast conservation therapy when administered in the neoadjuvant setting. (See protocol text for additional objectives and details).
Study Details
Timeline
Interventions
80 mg/m\^2 by vein (IV) Weekly Over 1 Hour x 12 Weeks
75 mg/m\^2 by vein (IV) Over 1 Hour Once Every 3 Weeks
1500 mg/m\^2 by mouth Twice Daily x 2 Weeks