Recruiting

To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With 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.

ClinicalTrials.gov IDNCT07368998

PhasePHASE2

Enrollment80

SponsorHoffmann-La Roche

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

Breast Cancer

About this study

Interventions

Drug: Inavolisib — Participants will receive Inavolisib as per the schedule given in the protocol.
Drug: Fulvestrant — Participants will receive Fulvestrant as per the schedule given in the protocol.

Primary outcomes

Percentage of Participants With Objective Response Rate (ORR) (Up to approximately 2 years)
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) (Up to approximately 2 years)

Eligibility information

Inclusion Criteria: * 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 Criteria: * 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

Study locations

Los Angeles Cancer Network, Los Angeles, California 90017-4803 United States
Cancer Specialists of North Florida, Jacksonville, Florida 32256 United States
HCA Midwest Division, Kansas City, Missouri 64132 United States
Astera Cancer Care East Brunswick, East Brunswick, New Jersey 08816 United States
Instituto de Oncologia de Rosario, Rosario, Santa Fe Province S2000KPG Argentina
Centro Oncologico Korben, Ciudad Autonoma Buenos Aires, C1426AGE Argentina
Hospital Privado - Centro Medico de Córdoba, Córdoba, 5016 Argentina
Centro Oncologico Riojano Integral (CORI), La Rioja, F5300COE Argentina
Hospital Provincial del Centenario, Rosario, S2002KDS Argentina
Centro Oncológico de Excelencia, San Juan, J5402BGA Argentina

Showing 10 of 34 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-26.