RO7771950 versus tucatinib with trastuzumab and capecitabine for HER2-positive locally advanced or metastatic breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2/3 randomized trial compares RO7771950 plus trastuzumab and capecitabine against tucatinib plus trastuzumab and capecitabine in adults with centrally confirmed HER2-positive locally advanced inoperable or metastatic breast cancer. Participants are randomized to one of the two combination regimens and treated until disease progression or unacceptable toxicity. Key eligibility includes at least one prior line of anti-HER2 therapy for advanced disease, allowance for prior antibody-drug conjugate exposure, and protocol-defined inclusion of patients with CNS or leptomeningeal metastases. Primary outcomes include tumor response, progression-free and overall survival, and safety/tolerability.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clearview Cancer Institute
  Huntsville, Alabama, United States Recruiting
• Banner Health MD Anderson AZ
  Gilbert, Arizona, United States Recruiting
• Community Cancer Institute (CCI)
  Clovis, California, United States Recruiting
• UC Davis Comprehensive Cancer Center
  Sacramento, California, United States Recruiting
• UCSF Helen Diller Family CCC
  San Francisco, California, United States Recruiting
• Eastern Connecticut Hematology and Oncology Associates
  Norwich, Connecticut, United States Recruiting

+169 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Reference Study ID Number: WO46069 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. only)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.