A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant Treatment With Inavolisib Combinations in Patients With Untreated, Early-stage, PIK3CA-Mutated Breast Cancer
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically confirmed operable or inoperable invasive Stage II-III BC according to American Joint Committee on Cancer (AJCC) TNM staging classification
• Candidate for neoadjuvant treatment and considered appropriate for endocrine combination therapy
• Willingness to undergo breast surgery (mastectomy or breast-conserving surgery) after neoadjuvant treatment (unless inoperable)
• Documented ER-positive tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
• Documented HER2-negative tumor in accordance with current ASCO/CAP guidelines
• Documented Ki-67 score \>=5% as per local assessment
• Confirmed PIK3CA mutation
Locations
Other Locations
Argentina
Centro Oncologico Korben
RECRUITING
Ciudad Autonoma Buenos Aires
Brazil
Hospital Araujo Jorge
RECRUITING
Goiânia
Irmandade Da Santa Casa de Misericordia de Porto Alegre
RECRUITING
Porto Alegre
Hospital do Cancer de Pernambuco - HCP
RECRUITING
Recife
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
RECRUITING
São Paulo
Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
RECRUITING
Montreal
Jewish General Hospital
RECRUITING
Montreal
McGill University Health Center
RECRUITING
Montreal
Sunnybrook Odette Cancer Centre
RECRUITING
Toronto
Germany
Das Brustzentrum
RECRUITING
Berlin
HELIOS Klinikum Berlin-Buch
RECRUITING
Berlin
Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden
RECRUITING
Dresden
Kliniken Essen-Mitte
RECRUITING
Essen
Universitätsklinikum Heidelberg
RECRUITING
Heidelberg
St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise
RECRUITING
Paderborn
HELIOS Klinikum Schwerin
RECRUITING
Schwerin
Republic of Korea
Asan Medical Center.
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Spain
Hospital Clinic Barcelona
RECRUITING
Barcelona
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
RECRUITING
Barcelona
Hospital General Universitario Gregorio Marañon
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Clinico Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Clínico Universitario de Valencia
RECRUITING
Valencia
Contact Information
Primary
Reference Study ID Number: BO45853 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date:2025-09-09
Estimated Completion Date:2027-09-28
Participants
Target number of participants:60
Treatments
Experimental: Arm A
Participants will receive inavolisib and letrozole orally (PO) once a day (QD) from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 1-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days).
Experimental: Arm B
Participants will receive a starting regimen of inavolisib and letrozole PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + letrozole as follows: inavolisib and letrozole PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days).
Experimental: Arm C
Participants will receive a starting regimen of ribociclib PO QD from Day 1 to 21 and letrozole PO QD from Day 1 to 28 in cycle 1 (each cycle=28 days). Starting on Day 1 of Cycle 2, all participants will receive the triplet regimen inavolisib + ribociclib + letrozole as follows: inavolisib and letrozole PO QD from Day 1 to 28 and ribociclib PO QD from Day 1 to 21 in cycles 2-5 (each cycle=28 days). In cycle 6, inavolisib, ribociclib and letrozole will be administered PO QD on days 1-21 (each cycle=21 days).