Tests inavolisib with standard drugs for advanced breast cancer with a PIK3CA mutation
Tests inavolisib with hormone and CDK4/6 drugs in adults with PIK3CA-mutated breast cancer.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Annapolis, Baltimore, Burbank, Charlotte, Cleveland, Detroit, Durham, East Brunswick, Edmonds, Everett, Florham Park, Fort Worth, Germantown, Goodyear, Grand Island, Grand Rapids, Greenville, Irvine, Jacksonville, Kansas City, La Jolla, Lexington, Long Beach, Los Alamitos, Los Angeles, Louisville, Marietta, Mayfield Heights, Minneapolis, Nashville, New York, O'Fallon, Omaha, Palo Alto, Phoenix, Pittsburgh, Portland, Salt Lake City, San Marcos, San Mateo, Seattle, Shirley, Spring, Springfield, Sunnyvale, Tacoma, Tallahassee, Tampa, The Bronx, Urbana, Weston, Winston-Salem, and Zion, United StatesSee the 62 sites
- Phase
- Phase 3
Where in United States
- Velocity Clinical ResearchAnnapolis, United StatesTaking people
- University of MarylandBaltimore, United StatesTaking people
- Disney Family Cancer CenterBurbank, United StatesTaking people
- Novant Health Cancer InstituteCharlotte, United StatesTaking people
- Cleveland Clinic FoundationCleveland, United StatesTaking people
- Fairview HospitalCleveland, United StatesTaking people
- Henry Ford Health SystemDetroit, United StatesTaking people
- Duke Cancer InstituteDurham, United StatesTaking people
- Astera Cancer Care - East BrunswickEast Brunswick, United StatesTaking people
- Swedish Cancer Institute - Edmonds CampusEdmonds, United StatesTaking people
- Providence Regional Cancer PartnershipEverett, United StatesTaking people
- Summit Medical GroupFlorham Park, United StatesTaking people
- JPS Health NetworkFort Worth, United StatesTaking people
- West Cancer CenterGermantown, United StatesTaking people
- City of Hope - PhoenixGoodyear, United StatesTaking people
- Nebraska Cancer SpecialistsGrand Island, United StatesTaking people
- Cancer & Hematology Centers of Western MichiganGrand Rapids, United StatesTaking people
- Bon Secours - St. Francis HospitalGreenville, United StatesTaking people
- City of Hope Lennar Foundation Cancer CenterIrvine, United StatesTaking people
- Cancer Specialists of North Florida - JacksonvilleJacksonville, United StatesTaking people
- HCA Midwest HealthKansas City, United StatesTaking people
- Scripps HealthLa Jolla, United StatesTaking people
- Baptist Health HamburgLexington, United StatesTaking people
- Baptist Health LexingtonLexington, United StatesTaking people
- University of Kentucky/Markey Cancer CenterLexington, United StatesTaking people
- City Of HopeLong Beach, United StatesTaking people
- Cancer and Blood Specialty ClinicLos Alamitos, United StatesTaking people
- Ellison Medical InstituteLos Angeles, United StatesTaking people
- Baptist Health LouisvilleLouisville, United StatesTaking people
- University of Louisville HospitalLouisville, United StatesTaking people
- Northwest Georgia Oncology Centers PC - MariettaMarietta, United StatesTaking people
- Hillcrest HospitalMayfield Heights, United StatesTaking people
- University of Minnesota Medical CenterMinneapolis, United StatesTaking people
- Vanderbilt University Medical CenterNashville, United StatesTaking people
- Icahn School of Medicine at Mount SinaiNew York, United StatesTaking people
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
- Mount Sinai WestNew York, United StatesTaking people
- The Blavatnik Family ? Chelsea Medical Center at Mount SinaiNew York, United StatesTaking people
- Cancer Care Specialists of Central IllinoisO'Fallon, United StatesTaking people
- Nebraska Cancer SpecialistsOmaha, United StatesTaking people
- Palo Alto Medical Foundation Research CenterPalo Alto, United StatesTaking people
- The Dignity Health Cancer InstitutePhoenix, United StatesTaking people
- UPMC Hillman Cancer Center - Magee-Women?s HospitalPittsburgh, United StatesTaking people
- Providence Oncology and Hematology Cancer Clinic - Westside;Investigation Drug Services PharmacyPortland, United StatesTaking people
- Providence Portland Medical CenterPortland, United StatesTaking people
- Huntsman Cancer Hospital at the University of UtahSalt Lake City, United StatesTaking people
- Kaiser Permanente-San MarcosSan Marcos, United StatesTaking people
- Palo Alto Medical Foundation Research CenterSan Mateo, United StatesTaking people
- Swedish Cancer InstituteSeattle, United StatesTaking people
- Swedish Cancer Institute - IssaquahSeattle, United StatesTaking people
- New York Cancer & Blood SpecialistsShirley, United StatesTaking people
- Community Clinical TrialsSpring, United StatesTaking people
- Springfield ClinicSpringfield, United StatesTaking people
- Palo Alto Medical Foundation Research CenterSunnyvale, United StatesTaking people
- Northwest Medical SpecialtiesTacoma, United StatesTaking people
- Tallahassee Memorial HealthcareTallahassee, United StatesTaking people
- Moffitt Cancer Center - McKinley CampusTampa, United StatesTaking people
- Montefiore Medical CenterThe Bronx, United StatesTaking people
- Carle Cancer CenterUrbana, United StatesTaking people
- Cleveland Clinic FloridaWeston, United StatesTaking people
- Novant Health Cancer InstituteWinston-Salem, United StatesTaking people
- City of Hope® Cancer Center ChicagoZion, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT06790693EU 2024-516162-11-00
- Record updated
- 4 November 2026
- Original description
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).Read full original descriptionShow less
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
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).
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: Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer; 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; Metaplastic 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; Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required; Any active bowel inflammation.