Inavolisib plus Fulvestrant with or without Palbociclib in PIK3CA-mutated HR+/HER2- Advanced Breast Cancer and Type 2 Diabetes

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 trial evaluates the safety of a triplet or doublet regimen in adults with PIK3CA-mutated, HR+/HER2-negative advanced breast cancer and type 2 diabetes. Participants receive inavolisib with fulvestrant, and may also receive palbociclib depending on eligibility. Eligibility requires measurable disease, good performance status, controlled diabetes on non-insulin therapy, and confirmed PIK3CA mutation. Exclusion criteria include pregnancy and a history of type 1 diabetes. The study is sponsored by Hoffmann-La Roche and sites in Washington, DC and Atlanta, GA.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Type 2 diabetes with laboratory fasting blood glucose \< 185 milligrams per deciliter (mg/dL) and HbA1c \<= 8% on any stable anti-hyperglycemic regimen excluding insulin short-term insulin dosing
* Eligible for triplet of inavolisib, fulvestrant and palbociclib: no prior systemic therapy for locally advanced unresectable or metastatic disease
* Confirmed diagnosis of HR+/HER2- breast cancer
* Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Adequate hematologic and organ function within 14 days prior to initiation of study treatment

Exclusion Criteria:

* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
* Metaplastic breast cancer
* Any history of Type 1 diabetes
* Severe hyper- or hypoglycemia event within 6 months of initiation of study treatment
* Any history of leptomeningeal disease or carcinomatous meningitis
* Known and untreated, or active central nervous system (CNS) metastases Participants with a history of treated CNS metastases are eligible
* Active inflammatory or conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
* Symptomatic active lung disease
* History of active bowel inflammation or active inflammatory bowel disease

Where it's running

• MedStar Washington Hosp Center
  Washington D.C., District of Columbia, United States Recruiting
• Grady Memorial Hospital
  Atlanta, Georgia, United States Recruiting
• Emory University Hospital Midtown
  Atlanta, Georgia, United States Recruiting
• Emory University Hospital
  Atlanta, Georgia, United States Recruiting
• Nebraska Cancer Specialists St Francis - Grand Island
  Grand Island, Nebraska, United States Recruiting
• Nebraska Cancer Specialists
  Omaha, Nebraska, United States Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: GO45322 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. and Canada)

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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.