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Looking for participantsPhase2/Phase3

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

NCT ID: NCT07413939

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
RO7771950 (drug), Tucatinib (drug), Trastuzumab (drug), Capecitabine (drug)
How long the study runs
Study runs about 76 months (dates as stated)
About the drug or intervention
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.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
650
Started
2026-05-21
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for her2-positive breast cancer
  • • Phase2/Phase3 - 650 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with her2-positive breast cancer

Where?

  • • Leicester - Leicester Royal Infirmary
  • • Liverpool - The Clatterbridge Cancer Centre NHS Foundation Trust
  • • London - Barts Health NHS Trust
  • • London - Royal Marsden Hospital - Sutton
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

HER2-positive Breast Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

HER2

Treatment history

Treatments you must have had:

  • ✓ of anti-HER2-based therapy f
  • ✓ TKIs f

What the study is looking for

  • ✓Pathologically documented that has grown locally inoperable (LAI) or that has spread breast cancer (MBC) with confirmed...
  • ✓cancer that can be measured on scans as per by (standard scan measurements) in stage 1. Non-cancer that can be measured on scans 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 that has spread disease.
  • ✓Prior tyrosine kinase inhibitor (TKI) in the (neo)after surgery setting provided completion is \> 12 months ahead of LAI...

Who cannot take part

  • ✗Concurrent anti-cancer treatment, or treatment with investigational therapy within 28 days prior to initiation of...
  • ✗Known active/untreated hepatitis B or C or chronic liver disease.
  • ✗Clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family...
  • ✗Concomitant use of any drug or herbal medicine known to strongly inhibit or induce CYP3A4 or CYP2C8 activity, oral...
See the full criteria
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.

Where Is This Study? (8 UK sites)

Leicester Royal Infirmary

Leicester LE2 7LG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool L7 8YA, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Maria Maguire

maria.maguire2@nhs.net0151 556 5321

Barts Health NHS Trust

London EC1A 7BE, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

Royal Marsden Hospital - Sutton

London SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Royal Marsden Hospital

London SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

UCLH

London WC1E 6AG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

Christie Hospital Nhs Trust

Manchester M20 4GJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

Musgrove Park Hospital

Montacute TA1 5DA, United Kingdom

Recruiting

How to Get in Touch

Reference Study ID Number: WO46069 https://forpatients.roche.com/ No attachments to email below.

Sponsor contact

CONTACT

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

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-10