At a glance
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A Randomized, Multicenter, Open-Label, Two-Arm, Phase III Neoadjuvant Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Patients With HER2-Positive Breast Cancer
In Brief
A Phase 3 clinical trial evaluating Carboplatin, Docetaxel, and 3 other interventions for Breast Neoplasms. Completed, enrolled 444 participants across 79 sites in 10 countries.
Detailed Summary
This is a randomized, multicenter, open-label, two-arm study in treatment-naive participants with operable, locally advanced, or inflammatory, centrally-assessed HER2-positive early breast cancer (EBC) whose primary tumors were greater than or equal to (\>/=) 2 centimeters (cm). The study was designed to evaluate the efficacy and safety of trastuzumab emtansine + pertuzumab (experimental arm; T-DM1 + P) versus chemotherapy, trastuzumab + pertuzumab (control arm; TCH + P). The study comprised a neoadjuvant treatment period, followed by surgery, and an adjuvant treatment period. Treatment can be stopped due to disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination.
Study Details
Timeline
Interventions
Carboplatin IV infusion at a dose to achieve an AUC of 6 mg\*min/mL q3w
Docetaxel 75 mg/m\^2 IV infusion q3w
Pertuzumab 840 mg (loading dose); and 420 mg (maintenance dose) IV infusion q3w
Trastuzumab 8 mg/kg (loading dose); and 6 mg/kg (maintenance dose) IV infusion q3w
Trastuzumab Emtansine 3.6 mg/kg IV infusion q3w