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

NCT07413939 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: WO460692025-524498-17-00
• Study Type: interventional
• Target: 650
• Locations: 2 countries
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) as Determined by Blinded Independent Central Review (BICR)

  Time from randomization to disease progression or death, according to standard criteria (Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)/Response Assessment in Neuro-oncology Brain Metastases (RANO-BM)).

  Approximately 35 months

Secondary Outcomes (20)

• Progression-free Survival in Participants with Central Nervous System Metastases (PFS-CNS) by BICR

  Approximately 35 months

• Overall Survival in Full Analysis Set (OS-FAS)

  Approximately 53 months

• Objective Response Rate (ORR) by BICR

  Approximately 35 months

• Duration of Response (DOR) as per BICR

  Approximately 35 months

• Clinical Benefit Rate (CBR) as per BICR

  Approximately 35 months

Study Arms (3)

Arm A - RO7771950 Dose Type 1

EXPERIMENTAL

Drug: RO7771950; Drug: Trastuzumab; Drug: Capecitabine

Arm B - RO7771950 Dose Type 2

EXPERIMENTAL

Drug: RO7771950; Drug: Trastuzumab; Drug: Capecitabine

Arm C - Tucatinib

ACTIVE COMPARATOR

Drug: Tucatinib; Drug: Trastuzumab; Drug: Capecitabine

Interventions

RO7771950 DRUG

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

Also known as: ZN-A-1041, RG6596

Arm A - RO7771950 Dose Type 1; Arm B - RO7771950 Dose Type 2

Tucatinib DRUG

Participants will receive a dose of tucatinib PO BID.

Arm C - Tucatinib

Trastuzumab DRUG

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

Arm A - RO7771950 Dose Type 1; Arm B - RO7771950 Dose Type 2; Arm C - Tucatinib

Capecitabine DRUG

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

Arm A - RO7771950 Dose Type 1; Arm B - RO7771950 Dose Type 2; Arm C - Tucatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically documented locally advanced inoperable (LAI) or metastatic breast cancer (MBC) with confirmed HER2-positive status by central laboratory
• Measurable disease only as per by RECIST v1.1/RANO-BM 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 for whom prior ADC therapy was not appropriate (e.g., due to lack of access or being medically unfit) may be considered for enrollment.
• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (4)

Hopital du Saint Sacrement

Québec, Quebec, G1S 4L8, Canada

RECRUITING

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, 00704, Taiwan

RECRUITING

National Taiwan Uni Hospital

Taipei, 10041, Taiwan

RECRUITING

MeSH Terms

Interventions

tucatinib; Trastuzumab; Capecitabine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: WO46069 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. only); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): September 29, 2032
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (1); TW (3)