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
- Inavolisib (drug), Ribociclib (drug), Fulvestrant (drug), Placebo (drug)
- How long the study runs
- Study runs about 46 months (dates as stated)
- About the drug or intervention
- Inavolisib — drug: Inavolisib will be administered as per the schedule mentioned in the protocol. · Ribociclib — drug: Ribociclib will be administered as per the schedule mentioned in the protocol. · Fulvestrant — drug: Fulvestrant will be administered as per the schedule mentioned in the protocol. · Placebo — drug: Placebo will be administered as per the schedule mentioned in the protocol.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 80
- Started
- 2026-04-07
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for breast cancer
- • Phase2 - 80 participants
- • A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with breast cancer
Where?
- • Leicester - Leicester Royal Infirmary
- • London - Royal Free Hospital
- • Manchester - Christie Hospital Nhs Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC).
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
What the study is looking for
- ✓Women or men with confirmed by testing a sample carcinoma of the breast that is that has grown locally or...
- ✓cancer that can be measured on scans per Response Evaluation Criteria in Solid Tumors, Version 1.1 ((standard scan measurements))
Who cannot take part
- ✗Metaplastic breast cancer
- ✗Radiotherapy within 2 weeks before randomization
- ✗Appropriate for treatment with cytotoxic drug treatment at time of entry into the study, as per national or local...
- ✗Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- ✗Any history of leptomeningeal disease or carcinomatous meningitis
See the full criteria
Where Is This Study? (3 UK sites)
Leicester Royal Infirmary
Leicester LE1 5WWi, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351Royal Free Hospital
London NW3 2QG, United Kingdom
Christie Hospital Nhs Trust
Manchester M20 4GJ, United Kingdom
How to Get in Touch
Reference Study ID Number: CO46274 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
