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A Study of ONT-380 vs. Placebo in Combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma

Study Summary

  • This study is a placebo controlled trial which means that you have a 2:1 odd of receiving study drug over placebo.
  • This study is double-blinded which means neither you nor your doctor will know if you are receiving the study drug
  • Treatments are given in cycles that each last 21 days.
    • Every day that you are on study, you will take 2 pills of ONT-380 or placebo orally. This is considered study drug which you will be provided free of charge, at your office visits corresponding with the start of each cycle of treatment.
    • Capecitabine (Xeloda) will be taken orally twice daily for the first 14 days of every cycle.
    • IV infusion of Trastuzumab (Herceptin) will be given once every cycle.  You will need to come into the cancer center for this treatment.
  • You will continue on treatment unless you would get sick from the treatment itself, your disease progresses, you decide you no longer want to participate or when the study closes.
  • The goal of this study is determine the success rate ONT-380 in combination with Capecitabine and Trastuzumab in treating HER2+ breast cancer. The goal of this study is to give patients who have already tried several other treatments for their disease another opportunity for treatment.
  • About 180 people will take part in this research study

Protocol

  • ONT-380-206

Phase

  • II

Investigator

  • Dr. Kenneth Blankstein

Disease

  • HER2+ Breast Cancer

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Inclusion

  • Pathology confirming HER2+ breast carcinoma
  • 18 or older
  • Able to carry out most daily tasks by yourself (ECOG Performance Status: <2)
  • Previous treatment for your breast cancer that included:
    •  Taxane therapy
    • Trastuzumab (Herceptin)
    • Pertuzumab (Perjeta)
    • T-DM1
  • Recent progression of disease or unresectable locally advanced or metastatic breast cancer

Exclusion

  • Prior treatment with:
    • Capecitabine (Xeloda)
    • Lapatinib
    • Neratinib
    • Afatinib
    • Any other investigational HER2/epidermal growth factor receptor (EGFR) or HER2 TKI
    • Exposure to anthracyclines in certain cumulative doses
  • Had any anti-cancer therapy within the 3 weeks before going on study
  • Have clinically significant cardiac disease; or had a myocardial infarction or unstable angina within 6 months prior to study
  • Known carriers of Hepatitis B or C. Known to be positive for HIV
  • Require warfarin therapy

NOTE: The inclusion and exclusion criteria for this study may be confusing, so if you are having a hard time deciding if you may be eligible, feel free to contact us!


If you have any questions regarding this study or think that
you or your loved one may be eligible, please feel free to contact:

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