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), Placebo (drug), CDK4/6i (drug), Letrozole (drug)
- How long the study runs
- Study runs about 82 months (dates as stated)
- About the drug or intervention
- Inavolisib — drug: Participants will receive oral inavolisib once daily (QD). · Placebo — drug: Participants will receive oral placebo QD. · CDK4/6i — drug: Participants will receive CDK4/6i on either Days 1-21 or Days 1-28 of each 28-day cycle. · Letrozole — drug: Participants will receive oral letrozole QD.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 450
- Started
- 2025-04-09
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for breast cancer
- • Phase3 - 450 participants
- • This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-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?
- • Blackpool - Blackpool Victoria Hospital
- • Colchester, Essex - Colchester General Hospital
- • Edinburgh - Western General Hospital
- • Harlow - Princess Alexandra Hospital
- • +5 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-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
- ✓Documented ER-positive and/or progesterone receptor-positive tumor according to American Society of Clinical...
- ✓Documented HER2-negative tumor according to ASCO/CAP guidelines
- ✓Participants who have bilateral breast cancers which are both HR-positive and HER2-negative
- ✓Confirmation of test result eligibility
Who cannot take part
- ✗Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which...
- ✗Metaplastic breast cancer
- ✗Any prior treatment that goes through your whole body for that has grown locally unresectable or that has spread breast cancer
- ✗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? (9 UK sites)
Blackpool Victoria Hospital
Blackpool FY3 8NR, United Kingdom
Colchester General Hospital
Colchester, Essex CO4 5JL, United Kingdom
Western General Hospital
Edinburgh EH4 2XU, United Kingdom
Princess Alexandra Hospital
Harlow CM20 1QX, United Kingdom
St Bartholomew's Hospital
London EC1M 6BQ, United Kingdom
Royal Free Hospital
London NW3 2QG, United Kingdom
Mount Vernon & Watford Hospital Trust
Northwood HA6 2RN, United Kingdom
Churchill Hospital - Oxford Cancer & Haematology Centre
Oxford OX3 7LE, United Kingdom
Weston Park Hospital
Sheffield S10 2SJ, United Kingdom
How to Get in Touch
Reference Study ID Number: WO45654 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
