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T-DM1 + Paclitaxel +/- Pertuzumab in HER2+ Metastatic Breast Cancer

NCT00951665Phase 2

Key facts

Status: Completed
Start: Aug 2009
Primary completion: Feb 2012
Countries: 1
Sponsor: Genentech
Modality: Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs), Small Molecules

Drugs: trastuzumab emtansine
Conditions: breast cancer

Overview

Phase 2, open-label trial of trastuzumab emtansine in breast cancer (6 arms), sponsored by Genentech. Primary endpoints: Number of Participants With Any Adverse Events, Serious Adverse Events, AEs of Grades 3/4, and Death, Number of Participants With Dose Limiting Toxicity up to 23 days and 6 more. Started Aug 2009; status: completed.

Design

6 arms

Study design: Non-randomizedOpen-label

Phase lb Regimen 1
T-DM1 Q3W + Paclitaxel QW
Phase Ib Regimen 2
T-DM1 Q3W + Paclitaxel QW + Pertuzumab Q3W
Phase Ib Regimen 3
T-DM1 QW + Paclitaxel QW
Phase Ib Regimen 4
T-DM1 QW + Paclitaxel QW + Pertuzumab Q3W
Phase IIa Group A
T-DM1 (MTD) + Paclitaxel
Phase IIa Group B
T-DM1 (MTD) + Paclitaxel + Pertuzumab

Who it enrols

Patients with HER2-positive locally advanced or metastatic breast cancer. Must have received prior trastuzumab (Phase Ib only) but no prior T-DM1 or pertuzumab. Adequate cardiac function (LVEF >= 50%) and life expectancy >= 90 days required. Excludes patients with significant peripheral neuropathy (Grade >= 2 for Phase Ib, >= 1 for Phase IIa) or high cumulative anthracycline exposure.

Endpoints

Primary

Number of Participants With Any Adverse Events, Serious Adverse Events, AEs of Grades 3/4, and DeathUp to 30 days post-treatment
Number of Participants With Dose Limiting ToxicityUp to 23 days
Maximum Tolerated Dose of T-DM1 and PaclitaxelDays 1 to 21
Number of Participants in Phase IIa Who Received 12 or More Paclitaxel Doses15 weeks
Number of Participants Who Had Adverse Events That Required Dose ModificationUp to 30 days post-treatment

Secondary

Objective Response RateEvery 2 cycles
Duration of Objective ResponseEvery 2 cycles
Percentage of Participants With Clinical BenefitEvery 2 cycles
Progression-free SurvivalEvery 2 cycles

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