Conditions: Metastatic Breast Cancer
Keywords: MBC Breast Cancer HER2+ HER2+ breast cancer HER2 positive breast cancer herceptin Trastuzumab emtansine
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 67
Healthy volunteers: no

Brief summary:
This was a multi-institutional, multinational, open-label, single-arm Phase Ib/II study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of trastuzumab emtansine (trastuzumab-MCC-DM1) administered by intravenous (IV) infusion in combination with pertuzumab in patients with human epidermal growth factor receptor-2 (HER2)-positive locally advanced or metastatic breast cancer who had previously received trastuzumab.

Detailed description:
There were 2 phases in the study, a Dose Escalation phase (Phase 1b) and a Dose Expansion phase (Phase 2a). In the Dose Escalation phase, 3 patients were enrolled at the first dose level (3.0 mg/kg trastuzumab emtansine) and and 6 patients were enrolled at the second dose level (3.6 mg/kg trastuzumab emtansine). An additional 58 patients were enrolled at the 3.6 mg/kg trastuzumab emtansine dose level in the Dose Expansion phase (Phase 2a) of the study.

Arms:
arm 1: Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle. arm 2: Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.

Interventions: intervention 1: Trastuzumab emtansine [Kadcyla] 3.0 mg/kg intervention 2: Trastuzumab emtansine [Kadcyla] 3.6 mg/kg intervention 3: Pertuzumab 420 mg
Intervention descriptions: intervention 1: Trastuzumab emtansine was provided as a single-use lyophilized formulation. intervention 2: Trastuzumab emtansine was provided as a single-use lyophilized formulation. intervention 3: Pertuzumab was provided as a single-use formulation.

Protocol document: