RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive

The purpose of this study is to assess the efficacy and safety of RO7771950 in combination with trastuzumab and capecitabine, compared to tucatinib in combination with trastuzumab and capecitabine.

Trial Details

NCT ID
NCT07413939
Phase
PHASE2 / PHASE3
Sponsor
Hoffmann-La Roche
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • RO7771950
  • Tucatinib
  • Trastuzumab
  • Capecitabine
Locations (sample)
  • Huntsville, Alabama, United States|34.7304,-86.58594
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Clovis, California, United States|36.82523,-119.70292
  • Sacramento, California, United States|38.58157,-121.4944
  • San Francisco, California, United States|37.77493,-122.41942

Key Eligibility Criteria

  • Pathologically documented locally advanced inoperable (LAI) or metastatic breast cancer (MBC) with confirmed HER2-positive status by central labora…
  • Measurable disease as per by RECIST v1.1 in stage 1. Non-measurable disease allowed in stage 2.
  • Previously treated (stable or progressive) or previously untreated CNS metastases, or leptomeningeal metastases.
  • At least one prior line of anti-HER2-based therapy for LAI or metastatic disease.

For full eligibility, visit ClinicalTrials.gov.

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