Status:
RECRUITING
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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-muta...
Eligibility Criteria
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
- Metaplastic breast cancer
- Prior treatment with chemotherapy in the recurrent locally advanced/metastatic 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 locally advanced/metastatic setting
- Requirement for daily supplemental oxygen
- Symptomatic active lung disease, including pneumonitis
Key Trial Info
Start Date :
February 27 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07368998
Start Date
February 27 2026
End Date
December 31 2031
Last Update
February 23 2026
Active Locations (11)
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1
Los Angeles Cancer Network
Los Angeles, California, United States, 90017-4803
2
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, United States, 08816
3
Hospital Universitario San Cecilio
Granada, Spain, 18016
4
Hospital Universitario 12 De Octubre
Madrid, Spain, 28041