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Protocol No. UW16005

Principal Investigator ORegan, Ruth

Phase II

Age Group Adult

Scope National

Sponsor Type Industry

Title Phase 2 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

Objective The purpose of this study is to test study treatments that combine an investigational drug (tucatinib, which is also known as ONT-380) with two approved drugs (capecitabine and trastuzumab) in patients with advanced breast cancer to find out what effects, good or bad, it may have on you and your disease.

Treatment 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 who have metastatic breast cancer that is positive for HER2 ("HER2+"). The test drug, tucatinib, is an experimental drug. The term "experimental" means that tucatinib is not approved by the FDA. This is the second study of the combination of tucatinib, capecitabine, and trastuzumab, and this is the fifth study of tucatinib tested in patients with advanced breast cancer. Eligible participants will be divided into two groups by random assignment (similar to the flip of a coin). One group will receive tucatinib, capecitabine, and trastuzumab. The other group will receive a placebo (a placebo is something that looks like medicine but is not actually medicine), capecitabine, and trastuzumab. Twice as many subjects will be assigned to the tucatinib group as will be assigned to the placebo.

Description Tucatinib and the placebo are in the form of tablets which will be taken by mouth twice each day. Capecitabine is also in the form of tablets which will be taken by mouth twice each day for the first 14 days of each 21-day treatment period (also known as a cycle). Trastuzumab will be given as an infusion (through a vein in your arm) once every 21 days. In certain situations your doctor may give you trastuzumab more than once every 21 days and will discuss that with you if it applies to you.

Key Eligibility
  • Have histologically confirmed HER2+ breast carcinoma
  • Have received previous treatment with a taxane, trastuzumab, pertuzumab, and T-DM1
  • Have progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy (as confirmed by investigator), or be intolerant of last systemic therapy
  • Patients will be excluded if they have previously been treated with lapatinib within 12 months of starting study treatment or neratinib, afatinib, or other investigational HER2/epidermal growth factor receptor (EGFR) or HER2 tyrosine kinase inhibitor (TKI) at any time previously
  • Patients will be excluded who have previously been treated with capecitabine for metastatic disease Note: Patients who have received capecitabine for adjuvant or neoadjuvant treatment at least 12 months prior to starting study treatment are eligible
  • Patients with history of exposure to the following cumulative doses of anthracyclines: Doxorubicin > 360 mg/m2, Epirubicin > 720 mg/m2, Mitoxantrone > 120 mg/m2, Idarubicin > 90 mg/m2, or Liposomal doxorubicin (e.g. Doxil, Caelyx, Myocet) > 550 mg/m2 will be excluded
  • Patients will be excluded if they have received treatment with any systemic anti-cancer therapy (including hormonal therapy), non-CNS radiation, or experimental agent ≤ 3 weeks of first dose of study treatment
  • Patients will be excluded who are known carriers of Hepatitis B or Hepatitis C or have other known chronic liver disease
  • Patients who are known to be positive for human immunodeficiency virus (HIV) are ineligible
  • Patients who are pregnant, breastfeeding, or planning a pregnancy are ineligible
  • Patients who require therapy with warfarin or other coumarin derivatives (non-coumarin anticoagulants are allowed) are ineligible
  • Patients will be excluded if they have any untreated brain metastases > 2.0 cm in size, unless discussed with medical monitor approval for enrollment is given. Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of > 2 mg of dexamethasone (or equivalent).However, patients on a chronic stable dose of ≤ 2 mg total daily of dexamethasone (or equivalent) may be eligible with discussion and approval by the medical monitor
  • Patients who have a brain lesion thought to require immediate local therapy are ineligible
  • Patients who have known or concurrent leptomeningeal disease (LMD) as documented by the investigator are excluded

Applicable Disease Sites Breast

Therapies Involved Cytotoxic Chemotherapy; Other

Drugs Involved Capecitabine; HER2/NEU (trastuzumab); ONT-380 (Tucatinib); Tucatinib; Xeloda (Capecitabine); anti-pi85 her2 monoclonal antibody (trastuzumab); herceptin (trastuzumab); rhuMAb HER2 (trastuzumab); trastuzumab

Status Open

Participating Institutions UW Hospital and Clinics