A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Inavolisib: Inavolisib will be administered as per the schedule specified in the arms
Ribociclib: Ribociclib will be administered as per the schedule specified in the arms
Letrozole: Letrozole will be administered as per the schedule specified in the arms
Giredestrant: Giredestrant will be administered as per the schedule specified in the arms
Study summary
This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC).
Eligibility
Primary outcome measure(s)
- Percentage of Participants with Adverse Events (AEs) — From first dose up to 30 days after last dose (approximately 8 months)
Trial sites (34)
| Facility | City | Region | Status |
|---|---|---|---|
| Los Angeles Cancer Network | Los Angeles | California | Recruiting |
| Community Clinical Trials | Orange | California | Recruiting |
| West Cancer Center | Germantown | Tennessee | Recruiting |
| West Virginia University | Morgantown | West Virginia | Recruiting |
| Hospital Aleman de Buenos Aires | Buenos Aires | Argentina | Recruiting |
| Centro Médico Fleischer | Buenos Aires | Argentina | Recruiting |
| Centro Oncologico Korben | Ciudad Autonoma Buenos Aires | Argentina | Recruiting |
| Hospital Araujo Jorge | Goiânia | Goiás | Recruiting |
| Hospital do Cancer de Pernambuco - HCP | Recife | Pernambuco | Recruiting |
| Irmandade Da Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Rio Grande do Sul | Recruiting |
| Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda | São Paulo | São Paulo | Recruiting |
| BC Cancer - Vancouver | Vancouver | British Columbia | Recruiting |
| Sunnybrook Odette Cancer Centre | Toronto | Ontario | Recruiting |
| Centre Hospitalier de l'Universite de Montreal (CHUM) | Montreal | Quebec | Recruiting |
| Jewish General Hospital | Montreal | Quebec | Recruiting |
| McGill University Health Center | Montreal | Quebec | Recruiting |
| Das Brustzentrum | Berlin | Germany | Recruiting |
| HELIOS Klinikum Berlin-Buch | Berlin | Germany | Recruiting |
| Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden | Dresden | Germany | Recruiting |
| Kliniken Essen-Mitte | Essen | Germany | Recruiting |
| Universitätsklinikum Heidelberg | Heidelberg | Germany | Recruiting |
| St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise | Paderborn | Germany | Recruiting |
| HELIOS Klinikum Schwerin | Schwerin | Germany | Recruiting |
| Seoul National University Hospital | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System | Seoul | South Korea | Recruiting |
| Asan Medical Center. | Seoul | South Korea | Recruiting |
| Samsung Medical Center | Seoul | South Korea | Recruiting |
| Vall d'Hebron Institute of Oncology (VHIO), Barcelona | Barcelona | Spain | Recruiting |
| Hospital Clinic Barcelona | Barcelona | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañon | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Recruiting |
| Hospital Clinico Universitario de Salamanca | Salamanca | Spain | Recruiting |
| Hospital Universitario Virgen Macarena | Seville | Spain | Recruiting |
| Hospital Clínico Universitario de Valencia | Valencia | Spain | Recruiting |
On this site
📄 Kisqali (ribociclib) drug profile →More Hoffmann-La Roche trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07054190 on ClinicalTrials.gov ↗ ← All trials in Spain