Inavolisib plus fulvestrant for PIK3CA‑mutated HR‑positive, HER2‑negative advanced breast cancer after CDK4/6 inhibitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional study enrolls participants with ER‑positive, HER2‑negative locally advanced or metastatic breast cancer who have a confirmed PIK3CA mutation and progression after CDK4/6 inhibitor plus endocrine therapy. Eligible participants receive inavolisib in combination with fulvestrant and are followed with tumor assessments per RECIST v1.1 and routine safety monitoring. The trial requires measurable or evaluable disease, life expectancy greater than six months, and collection of patient‑reported outcomes. Key outcomes include anti‑tumor activity, progression‑free intervals, and adverse event profiles.

Why it matters

Who can join: the full rules

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

Where it's running

• Los Angeles Cancer Network
  Los Angeles, California, United States Recruiting
• Cancer Specialists of North Florida
  Jacksonville, Florida, United States Recruiting
• HCA Midwest Division
  Kansas City, Missouri, United States Recruiting
• Astera Cancer Care East Brunswick
  East Brunswick, New Jersey, United States Recruiting
• Instituto de Oncologia de Rosario
  Rosario, Santa Fe Province, Argentina Recruiting
• Centro Oncologico Korben
  Ciudad Autonoma Buenos Aires, Argentina Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: WO46063 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.