To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
Recruiting now · Phase 2
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT07368998
- Run by
- Hoffmann-La Roche
- People needed
- 80
- Starts
- 2026-02-18
- Expected to finish
- 2031-10-31
- Last updated by the study team
- 2026-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Los Angeles Cancer Network — Los Angeles, California, United States (enrolling)
- Cancer Specialists of North Florida — Jacksonville, Florida, United States (enrolling)
- Astera Cancer Care East Brunswick — East Brunswick, New Jersey, United States (enrolling)
- Instituto de Oncologia de Rosario — Rosario, Santa Fe Province, Argentina (enrolling)
- Centro Oncologico Korben — Ciudad Autonoma Buenos Aires, Argentina (enrolling)
- Hospital Privado - Centro Medico de Córdoba — Córdoba, Argentina (enrolling)
- Centro Oncologico Riojano Integral (CORI) — La Rioja, Argentina (enrolling)
- Hospital Provincial del Centenario — Rosario, Argentina (enrolling)
- Centro Oncológico de Excelencia — San Juan, Argentina (enrolling)
- Blacktown Hospital — Blacktown, New South Wales, Australia (enrolling)
- Coffs Harbour Health Campus — Coffs Harbour, New South Wales, Australia (enrolling)
- Bendigo Cancer Centre — Bendigo, Victoria, Australia (enrolling)
- Cliniques Universitaires St-Luc — Brussels, Belgium (enrolling)
- Jessa Zkh (Campus Virga Jesse) — Hasselt, Belgium (enrolling)
- UZ Leuven Gasthuisberg — Leuven, Belgium (enrolling)
- Clinique Ste-Elisabeth — Namur, Belgium (enrolling)
- Hospital Civil de Guadalajara Fray Antonio Alcalde — Guadalajara, Jalisco, Mexico (enrolling)
- RENATI INNOVATION S.A.P.I. de C.V — Guadalajara, Jalisco, Mexico (enrolling)
- Centro de Infusion Tratamiento e Investigacion Oncologica S DE R — Queretaro Qro, Querétaro, Mexico (enrolling)
- CENEIT Oncologicos — Mexico City, Mexico (enrolling)
- Hospital Universitari Vall d'Hebron;Oncology — Barcelona, Spain (enrolling)
- Hospital Universitario San Cecilio — Granada, Spain (enrolling)
- Hospital Universitario 12 De Octubre — Madrid, Spain (enrolling)
- Hospital Clinico Universitario de Valencia — Valencia, Spain (enrolling)
- Bagcilar Medipol Mega Universitesi Hastanesi — Bağcılar, Istanbul, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
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