ClinicaliQ Trial Snapshot
- 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 — Recruiting • Phase II • Oncology • NCT07413939.
- Treatment being tested: RO7771950 (a novel HER2-directed tyrosine kinase inhibitor) combined with trastuzumab and capecitabine, compared against the established standard tucatinib-based regimen in HER2-positive advanced breast cancer.
- Patient eligibility overview: Adults with locally advanced or metastatic HER2-positive breast cancer; trial compares a new therapeutic agent against an existing evidence-based combination to determine potential clinical advantages.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : * Pathologically documented locally advanced inoperable (LAI) or metastatic breast cancer (MBC) with confirmed HER2-positive status by central laboratory. * 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. * Prior anti-HER2 antibody-drug conjugate (ADC), such as trastuzumab-deruxtecan (T-DXd) or trastuzumab emtansine (T-DM1), in any treatment setting. Participants without prior ADC therapy may only be enrolled if approved standard-of-care (SOC) anti-HER2 ADC is not locally accessible at screening, or if there is a prospectively documented clinical contraindication. * Prior tyrosine kinase inhibitor (TKI) in the (neo)adjuvant setting provided completion is > 12 months ahead of LAI occurrence. Prior treatment with TKIs for LAI/MBC is not permitted. * Has protocol-defined adequate organ and bone marrow function. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Baseline left ventricular ejection fraction (LVEF) ≥ 50%.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.