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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A - RO7771950 Dose Type 1
  • Drug: RO7771950
    Participants will receive one of two doses of RO7771950 orally (PO) twice a day (BID).
    Other names:
    • ZN-A-1041
    • RG6596
  • 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.
Experimental
Arm B - RO7771950 Dose Type 2
  • Drug: RO7771950
    Participants will receive one of two doses of RO7771950 orally (PO) twice a day (BID).
    Other names:
    • ZN-A-1041
    • RG6596
  • 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.
Active Comparator
Arm C - Tucatinib
  • 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.

Recruiting Locations

The West Clinic, PC dba West Cancer Center
Germantown, Tennessee 38138

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.