To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer (optINAVO)

Roche

Status and phase: Begins enrollment this month; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Fulvestrant; Drug: Inavolisib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07368998

WO46063

2025-522805-39-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Inavolisib Dose A plus Fulvestrant

Experimental group

Description:

Participants will recieve an inavolisib tablet orally (PO) along with fulvestrant as an intramuscular (IM) injection.

Treatment:

Drug: Fulvestrant

Drug: Inavolisib

Inavolisib Dose B plus Fulvestrant

Experimental group

Description:

Participants will recieve an inavolisib tablet PO along with fulvestrant as an IM injection.

Treatment:

Drug: Fulvestrant

Drug: Inavolisib