At a glance
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Single Arm, Neoadjuvant, Phase II Trial of Pertuzumab and Trastuzumab Administered Concomitantly With Weekly Paclitaxel and FEC for Clinical Stage I-II HER2-Positive Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Pertuzumab, Trastuzumab, and 4 other interventions for Her2-Positive Breast Cancer. Completed, enrolled 50 participants across 1 site.
Detailed Summary
The main goal of this clinical trial is to test if adding pertuzumab (Perjeta), improves the anticancer activity of the combination chemotherapy regimen of trastuzumab (Herceptin) concomitant with paclitaxel, 5-fluorouracil, epirubicin, and cyclophosphamide (T-FEC). The study will also test the safety of this therapy.
Study Details
Timeline
Interventions
First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)
For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total). For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).
Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).
Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).
Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).