Testing two inavolisib doses with fulvestrant in advanced PIK3CA-mutated breast cancer
Tests inavolisib with fulvestrant in adults with advanced PIK3CA-mutated breast cancer.
Key facts
- Who runs it
- Hoffmann-La Roche
- Where
- Blackpool, Harlow, Northwood, Middlesex, and Oxford, United KingdomSee the 4 sitesAlso in 7 other countries, 30 sites
- Trial code
- Registry title
- To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 80 people, planned
- Started
- 18 Feb 2026
- Expected to end
- 31 Oct 2031
- Type of study
- Interventional, 2 groups
- Treatments tested
- Inavolisib
- Fulvestrant
- Record updated
- 3 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with breast cancer that has spread or grown locally, has a PIK3CA mutation, is hormone receptor-positive and HER2-negative, and has worsened after CDK4/6 inhibitor treatment.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Locally advanced or metastatic breast cancer that is ER-positive and HER2-negative, with measurable or evaluable disease (RECIST v1.1). The disease worsened during or after CDK4/6i plus endocrine therapy.
- Earlier treatment
- Must have had a CDK4/6 inhibitor with endocrine therapy and no more than 1 earlier line of systemic therapy for advanced disease. No earlier chemotherapy and no earlier PI3K/Akt/mTOR inhibitor for recurrent locally advanced or metastatic disease.
- Biomarker or test result
- At least 1 study-listed PIK3CA mutation must be confirmed.
Main reasons for not taking part
- Metaplastic breast cancer
- Prior chemotherapy for recurrent locally advanced or metastatic disease
- Type 2 diabetes needing ongoing systemic treatment, or any history of Type 1 diabetes
- Prior PI3K/Akt/mTOR inhibitor for recurrent locally advanced or metastatic disease
- Need for daily extra oxygen, or symptomatic active lung disease such as pneumonitis
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- Documented ER +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
- Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: <= 1 prior lines of systemic therapy in the locally advanced (recurrent or progressed) or metastatic setting
- Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines
- Confirmation of biomarker eligibility: presence of >= 1 study-eligible PIK3CA mutation
- Life expectancy of > 6 months
- Ability, in the investigator's judgment, and willingness to comply with all study -related procedures, including completion of patient-reported outcomes
Who cannot take part
- Prior treatment with chemotherapy in the recurrent locally advanced/metastatic setting
- Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting
- Metaplastic breast cancer
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- Symptomatic active lung disease, including pneumonitis
- Requirement for daily supplemental oxygen
Where in United Kingdom
Also in 7 other countries, 30 sites
- Blackpool Victoria HospitalBlackpool, United KingdomTaking people
- Princess Alexandra HospitalHarlow, United KingdomTaking people
- Mount Vernon Cancer CentreNorthwood, Middlesex, United KingdomTaking people
- Churchill Hospital - Oxford Cancer & Haematology CentreOxford, United KingdomTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Inavolisib Dose A plus FulvestrantTreatment being tested
Participants will recieve an inavolisib tablet orally (PO) along with fulvestrant as an intramuscular (IM) injection.
Treatment: Inavolisib and Fulvestrant
- Inavolisib Dose B plus FulvestrantTreatment being tested
Participants will recieve an inavolisib tablet PO along with fulvestrant as an IM injection.
Treatment: Inavolisib and Fulvestrant
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
- Plain-language title
- Testing two inavolisib doses with fulvestrant in advanced PIK3CA-mutated breast cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 3 November 2026