Actively Recruiting
A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer
Led by Hoffmann-La Roche · Updated on 2026-04-20
80
Participants Needed
19
Research Sites
203 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) with chromosome 8p loss (chr8p loss) and without PIK3CA mutation.
CONDITIONS
Official Title
A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women or men with confirmed locally advanced or metastatic breast cancer not treatable with surgery or radiation aimed at cure
- Tumor must be estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive with at least 1% of tumor cells stained positive
- No previous systemic therapy for locally advanced or metastatic breast cancer
- Disease progressed during or within 12 months after completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen
- Confirmed lack of PIK3CA mutation and presence of chromosome 8p loss based on central lab testing of tumor tissue
- Measurable disease according to RECIST version 1.1
You will not qualify if you...
- Metaplastic breast cancer
- Radiotherapy received within 2 weeks before starting the study
- Need for cytotoxic chemotherapy at study entry as per guidelines (e.g., visceral crisis)
- Ongoing treatment for Type 2 diabetes or any history of Type 1 diabetes
- Known untreated or active central nervous system metastases requiring treatment; history of treated CNS metastases allowed
- Any history of leptomeningeal disease or carcinomatous meningitis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 19 locations
1
Avera Cancer Institute - Marshall
Marshall, Minnesota, United States, 56258
Actively Recruiting
2
Avera Cancer Institute - Aberdeen
Aberdeen, South Dakota, United States, 57401
Actively Recruiting
3
Avera Cancer Institute - Mitchell
Mitchell, South Dakota, United States, 57301
Actively Recruiting
4
Avera Cancer Institute - Pierre, SD
Pierre, South Dakota, United States, 57501
Actively Recruiting
5
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
6
AMG Oncology and Hematology Avera Cancer Institute - Yankton
Yankton, South Dakota, United States, 57078
Actively Recruiting
7
Centro Oncologico Korben
Caba, Argentina, C1426AGE
Actively Recruiting
8
Hospital Santa Rita de Cassia Vitoria
Vitória, Espírito Santo, Brazil, 29043-260
Actively Recruiting
9
Hospital Brasilia
Brasília, Federal District, Brazil, 71.635-610
Actively Recruiting
10
ICTR Curitiba
Curitiba, Paraná, Brazil, 80510-130
Actively Recruiting
11
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, Brazil, 01317-000
Actively Recruiting
12
CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital
Chicoutimi, Quebec, Canada, G7H 5H6
Actively Recruiting
13
McGill University
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
14
Soon Chun Hyang University Cheonan Hospital
Dongnam-gu, Cheonan-si, South Korea, 31151
Actively Recruiting
15
Gachon University Gil Medical Center
Namdong-Gu, South Korea, 21565
Actively Recruiting
16
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13605
Actively Recruiting
17
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
18
Hospital Universitario Clínico San Cecilio
Granada, Spain, 18016
Actively Recruiting
19
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
Research Team
R
Reference Study ID Number: CO46274 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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