Testing Inavolisib with CDK4/6i against a placebo for breast cancer
Official title: 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
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
Interventions
Inavolisib
Participants will receive oral inavolisib once daily (QD).
Placebo
Participants will receive oral placebo QD.
CDK4/6i
Participants will receive CDK4/6i on either Days 1-21 or Days 1-28 of each 28-day cycle.
Letrozole
Participants will receive oral letrozole QD.
Canadian Sites (12)
Arthur J.E. Child Comprehensive Cancer Center
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
The Moncton Hospital
Moncton, New Brunswick, Canada
The Ottawa Hospital Cancer Center
Ottawa, Ontario, Canada
Sault Area Hospital
Sault Ste. Marie, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Joseph's Health Centre
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Hôpital du Sacré-Coeur de Montreal
Montreal, Quebec, Canada
Unité de Recherche Clinique du CISSS de Laurentides
Saint-Jérôme, Quebec, Canada
Eligibility Criteria
See who this study is looking for22 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
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 biomarkerBiomarkerSomething measurable in the body used as a signal of what is happening.Read more → eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more →
- +ConsentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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
- −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
- −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
- −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
- −Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Inavolisib, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →, CDK4/6i, Letrozole.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 450 people.
The study is currently expected to finish around February 2032.
The main measurement is taken over: From randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Progression-Free Survival (PFS) — measured over From randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06790693 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About InavolisibDrug
Participants will receive oral inavolisib once daily (QD).
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Participants will receive oral placebo QD.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CDK4/6iDrug
Participants will receive CDK4/6i on either Days 1-21 or Days 1-28 of each 28-day cycle.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About LetrozoleDrug
Participants will receive oral letrozole QD.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years).
The study as a whole is currently expected to finish around 2032-02-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 450 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 18 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Winnipeg, Manitoba, Canada; Moncton, New Brunswick, Canada; Ottawa, Ontario, Canada; Sault Ste. Marie, Ontario, Canada, and 12 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).
Other Sites (13)
Henry Ford Health System
Detroit, Michigan, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
The Blavatnik Family ? Chelsea Medical Center at Mount Sinai
New York, New York, United States
Mount Sinai West
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Swedish Cancer Institute - Edmonds Campus
Edmonds, Washington, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Swedish Cancer Institute - Issaquah
Seattle, Washington, United States
Swedish Cancer Institute
Seattle, Washington, United States
Northwest Medical Specialties
Tacoma, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.