Adding inavolisib to ribociclib and fulvestrant for HR+ HER2- advanced breast cancer with chr8p loss

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 II randomized comparison gives participants either inavolisib plus ribociclib and fulvestrant or placebo plus ribociclib and fulvestrant to measure benefit and safety in a biomarker‑selected population. Eligibility requires central laboratory confirmation of chromosome 8p loss and absence of PIK3CA mutation, and participants must be in the first‑line metastatic setting after relapse on or soon after adjuvant endocrine therapy. Participants receive the assigned oral and injectable therapies on protocol schedules and are monitored for adverse events, tumor response, and time to disease progression. The sponsor is Hoffmann‑La Roche and the study is conducted at Avera Cancer Institute sites in Minnesota and South Dakota.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Women or men with histologically or cytologically confirmed carcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent
* Documented estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, defined as \>=1% of tumor cells stained positive based on the most recent tumor biopsy and assessed locally (Allison et al. 2020)
* Participants must not have received any prior systemic therapy for locally advanced unresectable or metastatic breast cancer (mBC) and must have progressed during adjuvant endocrine-based treatment or within 12 months after completing adjuvant endocrine-based therapy with an aromatase inhibitor or tamoxifen
* Confirmed biomarker eligibility as documented through central laboratory testing of a tumor tissue sample documenting both the lack of a phosphatidylinositol-4,5-biphosphate 3-kinase catalytic subunit alpha gene (PIK3CA) mutation and the presence of heterozygous loss of chromosome 8p (i.e., PIK3CAnmd and chr8p loss)
* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

Exclusion Criteria:

* Metaplastic breast cancer
* Radiotherapy within 2 weeks before randomization
* Appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines (e.g., participants with visceral crisis)
* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
* Known and untreated, or active Central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Participants with a history of treated CNS metastases are eligible
* Any history of leptomeningeal disease or carcinomatous meningitis

Where it's running

• Los Angeles Cancer Network - Anaheim
  Anaheim, California, United States Recruiting
• Stanford Cancer Institute
  Palo Alto, California, United States Recruiting
• Cancer Specialists of North Florida
  Jacksonville, Florida, United States Recruiting
• Avera Cancer Institute - Marshall
  Marshall, Minnesota, United States Recruiting
• Queens Hospital Cancer Center
  Jamaica, New York, United States Recruiting
• Avera Cancer Institute - Aberdeen
  Aberdeen, South Dakota, United States Recruiting

+9 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Reference Study ID Number: CO46274 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.