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NCT02073916 (STELA) (Clinical Trial/ Ado-Trastuzumab Emtansine)

Study Title
TDM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast Cancer (STELA) (NCT02073916)

Trial Description
This open-label, single-center study will assess the safety and tolerability of combining ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) to lapatinib (Tykerb®; Novartis Pharmacueticals Co.) and paclitaxel (Abraxane®; Celgene Corp.) 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 cycles for patients metastatic breast cancer, until disease progression or unacceptable toxicity occurs.

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.

This trial is sponsored by The Methodist Hospital System. [1]

Study Data

  • Condition: Metastatic Breast Cancer
  • Interventions:
  • Phase: I
  • Estimated Enrollment: 18
  • Start: October 2013
  • Estimated Completion: October 2015
  • Last verified: February 2014

Study Schematic

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Last Editorial review: July 31, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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