Recruiting
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.
ClinicalTrials.gov IDNCT07413939
PhasePHASE2, PHASE3
Enrollment650
SponsorHoffmann-La Roche
Age18 Years and older
SexALL
Conditions studied
HER2-positive Breast Cancer
About this study
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.
Interventions
- Drug: RO7771950 — Participants will receive one of two doses of RO7771950 orally (PO) twice a day (BID).
- Drug: Tucatinib — Participants will receive a dose of tucatinib PO BID.
- Drug: Trastuzumab — Participants will receive trastuzumab in accordance with local prescribing information, either through intravenous (IV) or subcutaneously (SC).
- Drug: Capecitabine — Participants will receive capecitabine according to local prescribing information. Capecitabine will be administered PO BID.
Primary outcomes
- Progression-free Survival (PFS) as Determined by Blinded Independent Central Review (BICR) (Approximately 35 months)
Eligibility information
Inclusion Criteria:
* 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%.
Exclusion Criteria:
* Concurrent anti-cancer treatment, or treatment with investigational therapy within 28 days prior to initiation of study treatment.
* Known active/untreated hepatitis B or C or chronic liver disease.
* Clinically significant cardiovascular disease or risk, including heart failure (New York Heart Association (NYHA) ≥ II), ischemic heart disease or recent coronary events/interventions, clinically significant arrhythmias or electrocardiogram (ECG) abnormalities, QT prolongation or risk of ventricular dysrhythmias, poorly controlled hypertension, peripheral arterial disease, dilated cardiomyopathy, or unstable angina.
* Clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome.
* Concomitant use of any drug or herbal medicine known to strongly inhibit or induce CYP3A4 or CYP2C8 activity, oral coumarin-derivative anticoagulants.
Study locations
- Clearview Cancer Institute, Huntsville, Alabama 35805 United States
- Banner Health MD Anderson AZ, Gilbert, Arizona 85234 United States
- UCSF Helen Diller Family CCC, San Francisco, California 94158 United States
- Eastern Connecticut Hematology and Oncology Associates, Norwich, Connecticut 06360 United States
- Astera Cancer Care East Brunswick, East Brunswick, New Jersey 08816 United States
- New York Oncology Hematology, P.C., Albany, New York 12206 United States
- New York Cancer and Blood Specialists, Shirley, New York 11967 United States
- Stony Brook Univ Cancer Ctr, Stony Brook, New York 11794 United States
- Montefiore Einstein Cancer Center, The Bronx, New York 10461 United States
- The West Clinic, PC dba West Cancer Center, Germantown, Tennessee 38138 United States
Showing 10 of 206 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-15.