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

Sponsor
Hoffmann-La Roche
Study ID
NCT07413939
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RO7771950 — DRUG
    Participants will receive one of two doses of RO7771950 orally (PO) twice a day (BID).
  • Tucatinib — DRUG
    Participants will receive a dose of tucatinib PO BID.
  • Trastuzumab — DRUG
    Participants will receive trastuzumab in accordance with local prescribing information, either through intravenous (IV) or subcutaneously (SC).
  • Capecitabine — DRUG
    Participants will receive capecitabine according to local prescribing information. Capecitabine will be administered PO BID.

Study Details

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.

Key Dates

First listed
Feb 17, 2026
Start date
May 21, 2026
Status verified
Jul 2026
Primary completion
May 1, 2029
Completion
Sep 29, 2032

Study Design

Enrollment
650 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A - RO7771950 Dose Type 1
  • Experimental: Arm B - RO7771950 Dose Type 2
  • Active Comparator: Arm C - Tucatinib

Primary Outcome Measure

Progression-free Survival (PFS) as Determined by Blinded Independent Central Review (BICR) [ Time Frame: Approximately 35 months ]

Central Contacts

  • Reference Study ID Number: WO46069 https://forpatients.roche.com/ No attachments to email below.
    888-662-6728 (U.S. only)
    [email protected]
  • Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

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