Actively Recruiting
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
Led by Hoffmann-La Roche · Updated on 2026-05-11
80
Participants Needed
19
Research Sites
297 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.
CONDITIONS
Official Title
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented estrogen receptor-positive and HER2-negative tumor as per ASCO/CAP guidelines
- Disease progression during or after treatment with CDK4/6 inhibitor plus endocrine therapy with \u2264 1 prior systemic therapy line in advanced or metastatic setting
- Measurable or evaluable disease based on RECIST version 1.1
- Recommended for endocrine-based therapy without indication for cytotoxic chemotherapy at study entry
- Presence of at least one eligible PIK3CA mutation
- Life expectancy greater than 6 months
- Ability and willingness to comply with all study procedures, including patient-reported outcomes
You will not qualify if you...
- Metaplastic breast cancer
- Prior chemotherapy treatment in recurrent locally advanced or metastatic setting
- Type 2 diabetes requiring ongoing systemic treatment or any history of Type 1 diabetes
- Previous treatment with PI3K/Akt/mTOR inhibitors in recurrent locally advanced or metastatic setting
- Need for daily supplemental oxygen
- Symptomatic active lung disease, including pneumonitis
AI-Screening
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Trial Site Locations
Total: 19 locations
1
Los Angeles Cancer Network
Los Angeles, California, United States, 90017-4803
Actively Recruiting
2
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, United States, 08816
Actively Recruiting
3
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, Argentina, C1426AGE
Actively Recruiting
4
Hospital Provincial del Centenario
Rosario, Argentina, S2002KDS
Actively Recruiting
5
Bendigo Cancer Centre
Bendigo, Victoria, Australia, 3550
Actively Recruiting
6
Cliniques Universitaires St-Luc
Brussels, Belgium, 1200
Actively Recruiting
7
Jessa Zkh (Campus Virga Jesse)
Hasselt, Belgium, 3500
Actively Recruiting
8
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
Actively Recruiting
9
Hospital Universitari Vall d'Hebron;Oncology
Barcelona, Spain, 08035
Actively Recruiting
10
Hospital Universitario San Cecilio
Granada, Spain, 18016
Actively Recruiting
11
Hospital Universitario 12 De Octubre
Madrid, Spain, 28041
Actively Recruiting
12
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
13
Bagcilar Medipol Mega Universitesi Hastanesi
Bağcılar, Istanbul, Turkey (Türkiye), 34214
Actively Recruiting
14
Adana Baskent University Hospital
Adana, Turkey (Türkiye), 01120
Actively Recruiting
15
Memorial Ankara Hastanesi
Ankara, Turkey (Türkiye), 06520
Actively Recruiting
16
Medical Park Seyhan Hospital
Seyhan, Turkey (Türkiye)
Actively Recruiting
17
Blackpool Victoria Hospital
Blackpool, United Kingdom, FY3 8NR
Actively Recruiting
18
Princess Alexandra Hospital
Harlow, United Kingdom, CM20 1QX
Actively Recruiting
19
Mount Vernon Cancer Centre
Northwood, Middlesex, United Kingdom, HA6 2RN
Actively Recruiting
Research Team
R
Reference Study ID Number: WO46063 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
2
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