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Treatment Study for HER2+ Breast Cancer

Clinical Trial Title: 
Phase 2 randomized, double-blinded, controlled study of ONT-380 vs. placebo in combination with capecitabine and trastuzumab in patients with pretreated unresectable locally advanced or metastatic HER2+ breast carcinoma.
Clinical Trial Protocol ID: 
15112405
Clinical Trial Investigator Name: 
Melody A. Cobleigh, MD
Clinical Trial Protocol Description: 

The purpose of this study is to test study treatments that combine an investigational drug (ONT-380) with two approved drugs (capecitabine and trastuzumab) in subjects with advanced breast cancer.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have received treatment with a taxane, trastuzumab, pertuzumab, and T-DM1.
  • Have CNS mets allowed with some stipulations.
  • Are able to have an MRI of the brain.

You will be excluded from the study if any of the following criteria apply to you:

  • Have previous treatment with lapatinib, neratinib, afatinib, or other HER2/EGFR or HER2 TKI.
  • Have previous treatment with capecitabine.
  • Have hepatitis B/C, HIV excluded.
  • Are currently taking warfarin.
  • Have leptomeningeal disease.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Breast Cancer
Contact Phone: 
(312) 942-3732
Contact Name: 
Chrystie Paul, RN, BSN