Actively Recruiting
A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
Led by Hoffmann-La Roche · Updated on 2026-04-27
60
Participants Needed
30
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed operable or inoperable invasive Stage II-III breast cancer
- Candidate for neoadjuvant treatment appropriate for endocrine combination therapy
- Willingness to undergo breast surgery after neoadjuvant treatment unless inoperable
- Documented estrogen receptor (ER)-positive tumor per ASCO/CAP guidelines
- Documented HER2-negative tumor per ASCO/CAP guidelines
- Documented Ki-67 score of 5% or higher
- Confirmed PIK3CA mutation
You will not qualify if you...
- Stage IV (metastatic) breast cancer
- Inflammatory breast cancer (cT4d)
- Bilateral invasive breast cancer
- History of ductal carcinoma in situ or lobular carcinoma in situ with prior systemic or radiation treatment to the same breast
- Previous systemic or local treatment for the primary breast cancer under study, including surgery or radiotherapy
- Type 2 diabetes requiring ongoing systemic treatment at study entry, or any history of Type 1 diabetes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
Community Clinical Trials
Orange, California, United States, 92868
Actively Recruiting
2
Hospital Aleman de Buenos Aires
Buenos Aires, Argentina, C1118AAT
Actively Recruiting
3
Centro Médico Fleischer
Buenos Aires, Argentina, C1414
Actively Recruiting
4
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, Argentina, C1426AGE
Actively Recruiting
5
Hospital Araujo Jorge
Goiânia, Goiás, Brazil, 74605-070
Actively Recruiting
6
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, Brazil, 50040-000
Actively Recruiting
7
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-074
Actively Recruiting
8
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, Brazil, 01317-000
Actively Recruiting
9
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
10
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada, H2X 0C2
Actively Recruiting
11
Jewish General Hospital
Montreal, Quebec, Canada, H3T1E2
Actively Recruiting
12
McGill University Health Center
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
13
Das Brustzentrum
Berlin, Germany, 12623
Actively Recruiting
14
HELIOS Klinikum Berlin-Buch
Berlin, Germany, 13125
Actively Recruiting
15
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, Germany, 01307
Actively Recruiting
16
Kliniken Essen-Mitte
Essen, Germany, 45136
Actively Recruiting
17
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
18
St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise
Paderborn, Germany, 33098
Actively Recruiting
19
HELIOS Klinikum Schwerin
Schwerin, Germany, 19055
Actively Recruiting
20
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
21
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
22
Asan Medical Center.
Seoul, South Korea, 05505
Actively Recruiting
23
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
24
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, Spain, 08035
Actively Recruiting
25
Hospital Clinic Barcelona
Barcelona, Spain, 08036
Actively Recruiting
26
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Actively Recruiting
27
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
28
Hospital Clinico Universitario de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
29
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
30
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
Research Team
R
Reference Study ID Number: BO45853 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here