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A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer

RecruitingPhase 2

A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant Treatment With Inavolisib Combinations in Patients With Untreated, Early-stage, PIK3CA-Mutated Breast Cancer

Who can join

Ages 18 and older · Women

Full eligibility criteria
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

About the study

This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC).

What is being tested

Sponsor: Hoffmann-La Roche · Participants: 120 · Started: Sep 9, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07054190

Locations in the U.S.

CaliforniaLos Angeles Cancer Network, Los Angeles
Community Clinical Trials, Orange
TennesseeWest Cancer Center, Germantown
TexasTexas Oncology - Central South, Austin
Texas Oncology - Northeast Texas, Flower Mound
West VirginiaWest Virginia University, Morgantown

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.