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Clinical Trials

Topic   Cancer - Breast Cancer
Title   ONT-380-206: Phase II Randomized, Double-Blinded, Controlled Study of Tucatinib vs. placebo in combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma
Summary   The aim of this study, which combines an investigational drug, Tucatinib (ONT-380) with two approved drugs, Capecitabine and Tratuzumab, is to evaluate the effects of Tucatinib, good or bad, in patients with advanced or metastatic HER2 positive breast cancer. Capecitabine and Trastuzumab are approved by the Food and Drug Administration (FDA) and are used either together or in combination with other drugs as part of the standard of care for patients with HER2 positive metastatic breast cancer.
Description   Patients will be randomized to one of two possible treatment regimens. Participants will receive Tucatinib in combination with Capecitabine and Trastuzumab or placebo in combination with Capecitabine and Trastuzumab. Tucatinib or placebo will be taken orally twice a day. Capecitabine will be taken orally twice a day in a 3 week cycle with 14 days on and 7 days off. Trastuzumab will be given intravenously every 3 weeks.
IRB Number   1044091
Inclusion/Notes   To be eligible to participate in this study, patients must meet several criteria including but not limited to the following: HER2 positive breast carcinoma; previous treatment with a taxane, Trastuzumab, Pertuzumab and T-DM1 (Kadcyla); have progression of locally advanced or metastatic breast cancer after last systemic therapy. Patients with brain metastases are eligible.
Status   Open
Start Date   05/05/2017
Principal Name   Nina D’Abreo, MD
Contact Name   Johanna Lee, RN
Email   JLee8@nyuwinthrop.org
Fax   516-663-1871
Current Trial Type   Interventional
Phone   516-663-1237
Alternate Phone   516-663-8391