Inavolisib and Fulvestrant for Advanced Breast Cancer

This study is looking at a combination of two drugs, Inavolisib and Fulvestrant, for people with locally advanced (cancer that has spread to nearby tissues) or metastatic (cancer that has spread to other parts of the body) breast cancer. Specifically, it's for those whose cancer is hormone receptor-positive (ER+), HER2-negative, and has a specific genetic change called PIK3CA mutation. You would have already received a type of treatment called a CDK4/6 inhibitor. The study aims to see how well this drug combination shrinks tumors and if it causes any side effects. We are looking for about 80 participants, aged 18 and older, of all genders. Your tumor must be ER+/HER2- and have the PIK3CA mutation to be eligible.

Study design
This interventional study plans to enroll 80 participants. The specific phase of the study is not mentioned.
What's involved
Participants will receive Inavolisib and Fulvestrant according to a schedule. The record does not specify the number of visits or other procedures.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 2 years to measure tumor response and side effects.

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NCT07368998

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Hoffmann-La Roche
~80 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:InavolisibFulvestrant

At a glance

Recruiting sites
31 of 31 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants With Objective Response Rate (ORR)
Measured over Up to approximately 2 years
+1 more outcome measured
Breast Cancer
31 sites across 15 states
Argentina5
Belgium4
Spain4
Turkey (Türkiye)3
United Kingdom3
New South Wales2
Jalisco2
California1
  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche
Reference Study ID Number: WO46063 https://forpatients.roche.com/ No attachments to email below.
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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
  • 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