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

ClinicalTrials.gov ID: NCT07413939

Public ClinicalTrials.gov record NCT07413939. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 17, 2026, 5:46 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Two-part, Seamless, Multicenter, Randomized, Open-label, Adaptive Phase II/III Study of the Blood-brain Barrier Penetrant RO7771950 Versus Tucatinib, Both in Combination With Trastuzumab and Capecitabine, in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2-Positive Breast Cancer, With or Without Central Nervous System Metastases

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07413939
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2, Phase 3
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 650 participants

Conditions and interventions

Conditions

HER2-positive Breast Cancer

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 21, 2026 (Actual)
Primary completion: May 1, 2029 (Estimated)
Completion: Sep 29, 2032 (Estimated)
Last update posted: Oct 6, 2026

2026 – 2032

United States locations

U.S. sites: 14
U.S. states: 8
U.S. cities: 13

Facility	City	State	ZIP	Site status
Clearview Cancer Institute	Huntsville	Alabama	35805	Recruiting
Banner Health MD Anderson AZ	Gilbert	Arizona	85234	Recruiting
UCSF Helen Diller Family CCC	San Francisco	California	94158	Recruiting
Eastern Connecticut Hematology and Oncology Associates	Norwich	Connecticut	06360	Recruiting
Astera Cancer Care East Brunswick	East Brunswick	New Jersey	08816	Recruiting
New York Oncology Hematology, P.C.	Albany	New York	12206	Recruiting
New York Cancer and Blood Specialists	Shirley	New York	11967	Recruiting
Stony Brook Univ Cancer Ctr	Stony Brook	New York	11794	Recruiting
Montefiore Einstein Cancer Center	The Bronx	New York	10461	Recruiting
The West Clinic, PC dba West Cancer Center	Germantown	Tennessee	38138	Recruiting
Sarah Cannon Research Institute	Nashville	Tennessee	37203-1632	Recruiting
Tennessee Oncology Elliston Place Plaza	Nashville	Tennessee	37203	Recruiting
Texas Oncology Cancer Center	Austin	Texas	78731	Recruiting
The Center for Cancer and Blood Disorders - Fort Worth	Fort Worth	Texas	76104	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 192 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07413939, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 6, 2026 · Synced Oct 17, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07413939 live on ClinicalTrials.gov.

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