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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (8 UK sites)
Leicester Royal Infirmary
Leicester LE2 7LG, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool L7 8YA, United Kingdom
Barts Health NHS Trust
London EC1A 7BE, United Kingdom
Royal Marsden Hospital - Sutton
London SW3 6JJ, United Kingdom
Royal Marsden Hospital
London SW3 6JJ, United Kingdom
UCLH
London WC1E 6AG, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825Christie Hospital Nhs Trust
Manchester M20 4GJ, United Kingdom
Musgrove Park Hospital
Montacute TA1 5DA, United Kingdom
How to Get in Touch
Reference Study ID Number: WO46069 https://forpatients.roche.com/ No attachments to email below.
Sponsor contactCONTACT
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Sponsor contactCONTACT
