At a glance
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Study Comparing the Efficacy and Safety of Epirubicin Combined With Cyclophosphamide Followed by Docetaxel (EC-T) Verses Paclitaxel Combined With Carboplatin (PCb) in the Adjuvant Chemotherapy of Non-triple Negative Breast Cancer
In Brief
A Phase 3 clinical trial evaluating Paclitaxel, Carboplatin, and 5 other interventions for Breast Cancer. Active but no longer recruiting, targeting 1,560 participants across 1 site.
Detailed Summary
This study is a randomized, single center, phase III clinical trial comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel (EC\*4-T\*4) verses 6 cycles of weekly paclitaxel combined with carboplatin (PCb\*6) in the adjuvant chemotherapy of non-triple negative breast cancer patients. The study is divided in to 2 branches: PANSY-1 and PANSY-2. PANSY-1 is a study of hormone receptor (HR)-positive/human epidermal growth factor receptor-2 (HER2)-negative patients with ≥4 positive lymph node, while PANSY-2 is a study of HER2-positive patients with ≥1 positive lymph node.
Study Details
Timeline
Interventions
paclitaxel 80 mg/m\^2 ivgtt d1, d8, d15, 28 days per cycle, 6 cycles.
carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle, 6 cycles.
epirubicin 90 mg/m\^2 ivgtt d1, 21 days per cycle, 4 cycles.
cyclophosphamide 600 mg/m\^2 iv d1, 21 days per cycle, 4 cycles.
trastuzumab 6 mg/kg (loading dose 8mg/kg) ivgtt d1, 21 days per cycle with chemotherapy; or trastuzumab 2 mg/kg (loading dose 4mg/kg, w1) ivgtt d1, d8, d15, d22, 28 days per cycle with chemotherapy. After chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab (6 mg/kg ivgtt every 3 weeks).
pertuzumab 420mg (loading dose 840mg) ivgtt d1, 21 days per cycle with chemotherapy. After chemotherapy, patient will continue to complete 1 year of adjuvant pertuzumab (420mg ivgtt every 3 weeks).
docetaxel 100 mg/m\^2 ivgtt d1, 21 days per cycle, 4 cycles.