Recruiting
Phase 2
Phase 3

RO7771950 & Tucatinib

Sponsor:

Hoffmann-La Roche

Code:

NCT07413939

Conditions

HER2-positive Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RO7771950

Tucatinib

Trastuzumab

Capecitabine

Study Details

Brief summary:

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.

Conditions

HER2-positive Breast Cancer

Study ID

NCT07413939

Start date

May 21, 2026

Status verified date

Sep, 2026

Completion date

Sep 29, 2032

Anticipated

Primary completion date

May 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

650 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A - RO7771950 Dose Type 1

experimental: Arm B - RO7771950 Dose Type 2

active comparator: Arm C - Tucatinib

Interventions

RO7771950

Participants will receive one of two doses of RO7771950 orally (PO) twice a day (BID).

Tucatinib

Participants will receive a dose of tucatinib PO BID.

Trastuzumab

Participants will receive trastuzumab in accordance with local prescribing information, either through intravenous (IV) or subcutaneously (SC).

Capecitabine

Participants will receive capecitabine according to local prescribing information. Capecitabine will be administered PO BID.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

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

Locations

Astera Cancer Care East Brunswick

Recruiting

East Brunswick, New Jersey, United States, 08816

New York Oncology Hematology, P.C.

Recruiting

Albany, New York, United States, 12206

New York Cancer and Blood Specialists

Recruiting

Shirley, New York, United States, 11967

The West Clinic, PC dba West Cancer Center

Recruiting

Germantown, Tennessee, United States, 38138

Ottawa General Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Sunnybrook Odette Cancer Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Princess Margaret Cancer Center

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Hopital Charles Le Moyne

Recruiting

Greenfield Park, Quebec, Canada, J4V 2H1

Hopital Maisonneuve-Rosemont

Recruiting

Montreal, Quebec, Canada, H1T 2M4

CHUM

Recruiting

Montreal, Quebec, Canada, H2L 4M1

McGill University Health Centre - Glen Site

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Hospital Du Saint-Sacrement

Recruiting

Québec, Quebec, Canada, G1S 4L8

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-28. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-09-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.