Testing two inavolisib doses with fulvestrant in advanced PIK3CA-mutated breast cancer
Tests inavolisib with fulvestrant in adults with advanced PIK3CA-mutated breast cancer.
Plain-language title generated from the registry record
Registry title: To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
Key facts
- Where
- Barcelona, Granada, Madrid, and Valencia, SpainSee the 4 sites
- Phase
- Phase 2
Where in Spain
- Fundació Hospital Universitari Vall d'Hebron - Institut de RecercaBarcelona, SpainTaking people
- Hospital Universitario Clínico San CecilioGranada, SpainTaking people
- Hospital Universitario 12 de OctubreMadrid, SpainTaking people
- Hospital Clinico Universitario de ValenciaValencia, SpainTaking people
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?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT07368998EU 2025-522805-39-00
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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.