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Study of Inavolisib for Early-Stage, PIK3CA-Mutated Breast Cancer

This study is looking at new ways to treat early-stage breast cancer that has a specific gene change called PIK3CA mutation. It's for women with Stage II-III, ER-positive, HER2-negative breast cancer who haven't been treated yet. You would receive a combination of medicines: Inavolisib, Ribociclib, and Letrozole. The main goal is to see how safe these treatments are by tracking any side effects you might experience for about 8 months after your last dose. The study aims to enroll 60 participants.

Study design
This is an interventional study with an enrollment goal of 60 participants. The phase is not specified.
What's involved
You would receive Inavolisib, Ribociclib, and Letrozole as per the study schedule. You would also need to be willing to have breast surgery after the treatment.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be measured up to 30 days after your last dose, which is approximately 8 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07054190

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Hoffmann-La Roche
~60 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:InavolisibRibociclibLetrozole

At a glance

Recruiting sites
33 of 33 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants with Adverse Events (AEs)
Measured over From first dose up to 30 days after last dose (approximately 8 months)

Conditions

Breast Cancer

Explore related trials

Breast CarcinomaMKI67 GenePIK3CA Gene

Where it's being run

33 sites across 13 states
Germany7
Spain7
South Korea4
Argentina3
Quebec3
California2
Tennessee1
West Virginia1

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: BO45853 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728 (U.S. and Canada)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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, including 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

What this trial measures

  • Percentage of Participants with Adverse Events (AEs)From first dose up to 30 days after last dose (approximately 8 months)