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), Fulvestrant (drug)
- How long the study runs
- Study runs about 68 months (dates as stated)
- About the drug or intervention
- Inavolisib — drug: Participants will receive Inavolisib as per the schedule given in the protocol. · Fulvestrant — drug: Participants will receive Fulvestrant as per the schedule given 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
- 2026-02-18
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for breast cancer
- • Phase2 - 80 participants
- • The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with breast cancer
Where?
- • Blackpool - Blackpool Victoria Hospital
- • Harlow - Princess Alexandra Hospital
- • Northwood, Middlesex - Mount Vernon Cancer Centre
- • Oxford - Churchill Hospital - Oxford Cancer & Haematology Centre
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.
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
- ✓Documented ER +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists...
- ✓Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 ((standard scan measurements))
- ✓Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic drug treatment is not...
- ✓Confirmation of test result eligibility: presence of \>= 1 study-eligible PIK3CA mutation
- ✓Life expectancy of \> 6 months
Who cannot take part
- ✗Metaplastic breast cancer
- ✗Prior treatment with drug treatment in the recurrent that has grown locally/that has spread setting
- ✗Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- ✗Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent that has grown locally/that has spread setting
- ✗Requirement for daily supplemental oxygen
See the full criteria
Where Is This Study? (4 UK sites)
Blackpool Victoria Hospital
Blackpool FY3 8NR, United Kingdom
Princess Alexandra Hospital
Harlow CM20 1QX, United Kingdom
Mount Vernon Cancer Centre
Northwood, Middlesex HA6 2RN, United Kingdom
Churchill Hospital - Oxford Cancer & Haematology Centre
Oxford OX3 7LE, United Kingdom
How to Get in Touch
Reference Study ID Number: WO46063 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
