Extrait

This open-label, single-center study will assess the safety and tolerability of combining trastuzumab emtansine (T-DM1) to Lapatinib and Abraxane in patients with metastatic HER2-positive breast cancer. Patients will receive Abraxane on Day 1 of each 1-week cycle and T-DM1 on Day 1 of each 3-week cycle. Patients with take Lapatinib orally daily. Anticipated time on study treatment is up to 12 weeks for patients metastatic breast cancer, until disease progression or unacceptable toxicity occurs. Subjects may continue on treatment past 12 weeks if responding to study treatment. The purpose of this study is to test the safety of Trastuzumab Emtansine in combination with Abraxane and Lapatinib at different dose levels. The investigators are proposing in this phase Ib study to assess the maximum tolerated dose (MTD) of Trastuzumab Emtansine in combination with Lapatinib plus Abraxane in metastatic Her2 over-expressed breast cancer. The investigators hypothesize that combining antibody-drug conjugate trastuzumab-emtansine and lapatinib together with Abraxane will improve clinical efficacy by affecting both PI3K and ERK1,2 MAPK pathways.

Critère d'inclusion

• Metastatic breast cancer

Liens

• ictrp
• nct