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.
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).
Alison Conlin, M.D.
- Oncology and Hematology Care Eastside
- Oncology and Hematology Care Newberg
- Oncology and Hematology Care Southeast
- Oncology and Hematology Care Westside