Inavolisib plus endocrine therapy for early-stage PIK3CA‑mutated ER+ HER2‑ breast cancer

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 neoadjuvant trial enrolls people with untreated, operable or inoperable Stage II–III ER‑positive, HER2‑negative breast cancer that harbors a confirmed PIK3CA mutation. Participants receive inavolisib in combination with ribociclib and letrozole prior to planned breast surgery, with treatment safety and tumor response tracked over the neoadjuvant period. Key entry requirements include a Ki‑67 ≥5% and willingness to undergo mastectomy or breast‑conserving surgery after therapy when appropriate. Outcomes will include measures of tumor shrinkage and safety/tolerability to inform whether this targeted combination improves preoperative control of PIK3CA‑mutant disease.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed operable or inoperable invasive Stage II-III BC according to American Joint Committee on Cancer (AJCC) TNM staging classification
* Candidate for neoadjuvant treatment and considered appropriate for endocrine combination therapy
* Willingness to undergo breast surgery (mastectomy or breast-conserving surgery) after neoadjuvant treatment (unless inoperable)
* Documented ER-positive tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
* Documented HER2-negative tumor in accordance with current ASCO/CAP guidelines
* Documented Ki-67 score \>=5% as per local assessment
* Confirmed PIK3CA mutation

Exclusion Criteria:

* Stage IV (metastatic) BC
* Inflammatory BC (cT4d)
* Bilateral invasive BC
* History of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for treatment or radiation therapy to the ipsilateral breast
* Previous systemic or local treatment for the primary BC currently under investigation (including excisional biopsy or any other surgery of the primary tumor and/or axillary lymph nodes, and sentinel lymph node biopsy, radiotherapy, cytotoxic, and endocrine treatments)
* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes

Where it's running

• Los Angeles Cancer Network
  Los Angeles, California, United States Recruiting
• Community Clinical Trials
  Orange, California, United States Recruiting
• West Cancer Center
  Germantown, Tennessee, United States Recruiting
• Texas Oncology - Central South
  Austin, Texas, United States Recruiting
• Texas Oncology - Northeast Texas
  Flower Mound, Texas, United States Recruiting
• West Virginia University
  Morgantown, West Virginia, United States Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: BO45853 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.