NCT06790693Recruiting
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
Summary
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 criteria
• 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 criteria
• 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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, United States, Argentina, Australia, Brazil, Canada, China, Japan, Mexico, Poland, Puerto Rico, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
- Sponsor
- Hoffmann-La Roche(Industry)
- Protocol no.
- WO45654
- Conditions
- Breast Cancer
- Interventions
- Drug
Treatments studied
- Inavolisib
- Placebo
- CDK4/6i
- Letrozole
Locations · 240
- Baden, SwitzerlandKantonsspital Baden Zentrum für Onkologie und HämatologieRecruiting at this site
- Basel, SwitzerlandUniversitätsspital BaselRecruiting at this site
- Lausanne, SwitzerlandCHUVRecruiting at this site
- Lucerne, SwitzerlandLuzerner KantonsspitalRecruiting at this site
- Angers, FranceICO Paul PapinRecruiting at this site
- Lille, FranceCentre Oscar LambretRecruiting at this site
- Montpellier, FranceCentre Cancerologie Grand MontpellierRecruiting at this site
- Paris, FranceINSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.Recruiting at this site
- Plérin, FranceCentre CARIO - HPCARecruiting at this site
- Poitiers, FranceChu La MiletrieRecruiting at this site
- Rennes, FranceCentre Eugene MarquisRecruiting at this site
- Rouen, FranceCentre Henri BecquerelRecruiting at this site
- Saint-Cloud, FranceHOPITAL RENE HUGUENIN- Institut CurieRecruiting at this site
- Saint-Herblain, FranceIco Rene GauducheauRecruiting at this site
- Toulouse, FranceInstitut Universitaire de Cancer de Toulouse OncopoleRecruiting at this site
- Villejuif, FranceGustave RoussyRecruiting at this site
- Cologne, GermanySt. Elisabeth Krankenhaus Köln GmbHRecruiting at this site
- Dresden, GermanyUniversitätsklinikum "Carl Gustav Carus" der Technischen Universität DresdenRecruiting at this site
- Essen, GermanyUniversitätsklinikum EssenRecruiting at this site
- Essen, GermanyKlinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbHRecruiting at this site
- Hamburg, GermanyKooperatives Mammazentrum Hamburg Krankenhaus JerusalemRecruiting at this site
- Hanover, GermanyMedizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische OnkologieRecruiting at this site
- Heidelberg, GermanyNationales Centrum für Tumorerkrankungen (NCT)Recruiting at this site
- Koblenz, GermanyInVO - Institut für Versorgungsforschung in der Onkologie GbRRecruiting at this site
- Langen, GermanyDres. Andreas Köhler und Roswitha FuchsRecruiting at this site
- Münster, GermanyUniversitätsklinikum MünsterRecruiting at this site
- Potsdam, GermanyKlinikum Ernst von BergmannRecruiting at this site
- Regensburg, GermanyCaritas-Krankenhaus St. JosefRecruiting at this site
- Saarbrücken, GermanyCaritas Klinik St. Theresia -Frauenklinik BrustzentrumRecruiting at this site
- Tübingen, GermanyUniversitätsklinik TübingenRecruiting at this site
In total, worldwide, 240 of the 242 sites listed in the registry are recruiting; the other 2 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 6, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 210 more locations
Other identifiers
- 2024-516162-11-00 · other registry
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.