RWF_ONT-380-206

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

The purpose of this study is to assess the effect of ONT-380 vs. placebo in combination with capecitabine and trastuzumab on both central nervous system (CNS) and non-CNS progression-free survival (PFS) based on independent central review.

Inclusion Criteria:

Patients must meet the following criteria to be eligible for the study:

*Have histologically confirmed HER2+ breast carcinoma, with HER2+ defined by fluorescence in situ hybridization (FISH) and/or 3+ staining by immunohistochemistry (IHC) a. Tissue blocks or slides must be submitted to confirm HER2 positivity (FISH-positive or IHC 3+) by a sponsor-designated central laboratory prior to randomization. Centrally confirmed HER2 results (either IHC or FISH) from a previous study can be used to determine eligibility for this study with approval from the sponsor.

*Have received previous treatment with a taxane, trastuzumab, pertuzumab, and T-DM1

*Have one of the following:

-If both pertuzumab and T-DM1 were administered for metastatic or locally advanced unresectable breast cancer, must be at least 6 months since diagnosis of metastatic or locally advanced unresectable breast cancer.

-If either pertuzumab or T-DM1 was administered in the neo-adjuvant or adjuvant setting (and the other administered for metastatic or locally advanced unresectable breast cancer), must be at least 3 months since diagnosis of metastatic or locally advanced unresectable breast cancer.

-If both pertuzumab and T-DM1 were administered in the neo-adjuvant or adjuvant setting, must have completed adjuvant treatment at least 12 months prior to enrollment.

*Have progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy (as confirmed by investigator).
Phase II
NCT02614794
Cancer, All Other
Breast
Alison Conlin, M.D.
Cascadian Therapeutics (formerly Oncothyreon)
Nikki Moxon
  • Oncology and Hematology Care Eastside
  • Oncology and Hematology Care Newberg
  • Oncology and Hematology Care Southeast
  • Oncology and Hematology Care Westside