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A Study of Inavolisib for Advanced Breast Cancer

This study is looking at a new treatment for advanced breast cancer that is hormone receptor-positive (HR+), HER2-negative, and has a specific gene change called PIK3CA mutation. You might be eligible if you are 18 or older and have this type of breast cancer. The study compares a combination of medicines: inavolisib, a CDK4/6 inhibitor, and letrozole, against a placebo (an inactive substance) plus a CDK4/6 inhibitor and letrozole. Researchers want to see if adding inavolisib helps prevent the cancer from growing or spreading (this is called progression-free survival, or PFS). This is measured for up to 7 years. The study aims to enroll about 450 participants.

Study design
This is an interventional study comparing two treatment combinations. It plans to enroll about 450 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 7 years to track disease progression or death.

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

NCT06790693

A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

Recruiting
PHASE3Ages 18+InterventionalTreatment
Hoffmann-La Roche
~450 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:InavolisibPlaceboCDK4/6iLetrozole

At a glance

Recruiting sites
237 of 239 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS)
Measured over From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years)

Conditions

Breast Cancer

Explore related trials

Breast CarcinomaPIK3CA Gene

Where it's being run

239 sites across 73 states
China19
Germany15
France12
Spain11
California10
Japan10
Poland10
South Korea9

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: WO45654 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728 (U.S. Only)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Women or men with histologically or cytologically confirmed carcinoma of the breast
Documented ER-positive and/or progesterone receptor-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
Documented HER2-negative tumor according to ASCO/CAP guidelines
De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy without disease progression during that treatment and disease-free interval of at least 1 year since the completion of that treatment
Participants who have bilateral breast cancers which are both HR-positive and HER2-negative
Confirmation of biomarker eligibility
Consent to provide fresh or archival tumor tissue specimen
Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Adequate hematologic and organ function within 14 days prior to initiation of study treatment

Exclusion

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 prior systemic therapy for locally advanced unresectable or metastatic breast cancer
Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
Any history of leptomeningeal disease or carcinomatous meningitis
Known and untreated, or active CNS metastases. Participants with a history of treated CNS metastases are eligible
Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
Symptomatic active lung disease
History of or active inflammatory bowel disease
Any active bowel inflammation
Prior hematopoietic stem cell or bone marrow transplantation
Treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 4 weeks or 5 drug-elimination half-lives, prior to initiation of study treatment

What this trial measures

  • Progression-Free Survival (PFS)From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years)