Actively Recruiting
A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
Led by Hoffmann-La Roche · Updated on 2026-04-20
500
Participants Needed
17
Research Sites
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main purpose of this study is to evaluate the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (LA/mBC), following on or after completing adjuvant endocrine therapy in routine clinical practice in China.
CONDITIONS
Official Title
A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be diagnosed with endocrine-resistant, PIK3CA-mutated, HR+/HER2- LA/mBC, following recurrence on or after completing adjuvant endocrine therapy
- Participants must receive the treatment of inavolisib for the first time
- PIK3CA mutation status should be detected by a National Medical Products Administration (NMPA)-approved or validated assay [Polymerase Chain Reaction (PCR) or Next Generation Sequencing (NGS)] by testing of blood or tumor tissue prior to the initiation of inavolisib
You will not qualify if you...
- Participants for which the treatment with inavolisib is not indicated per prescribing information. If the participant starts palbociclib and fulvestrant first, and starts inavolisib after getting a PIK3CA mutation-positive test result later, the palbociclib and fulvestrant will not be deemed as a different line of therapy. However, the medical order of PIK3CA mutation test must be made before or at the same time with the prescription of palbociclib and fulvestrant
- Participants not receiving treatment for LA/mBC with inavolisib according to standard of care (SOC) and in line with the current summary of product characteristics (SPC)/local labeling
- At the investigator's discretion, any reason that makes the participant hard to follow up or unsuitable to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine)
Lanzhou, Gansu, China, 730050
Actively Recruiting
2
Wenzhou Medical University Affiliated Second Hospital
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
3
Peking University First Hospital
Beijing, China, 100034
Actively Recruiting
4
Peking University Third Hospital
Beijing, China, 100191
Actively Recruiting
5
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, China, 610072
Actively Recruiting
6
Chongqing Cancer Hospital
Chongqing, China, 400030
Actively Recruiting
7
Zhujiang Hospital, Southern Medical University
Guangzhou, China, 510280
Actively Recruiting
8
Harbin Medical University Cancer Hospital
Harbin, China, 150081
Actively Recruiting
9
Shandong Provincial Hospital
Jinan, China, 250021
Actively Recruiting
10
Jiangxi Cancer Hospital
Nanchang, China, 330006
Actively Recruiting
11
Jiangsu Province Hospital
Nanjing, China, 210029
Actively Recruiting
12
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
13
Shanxi Provincial Cancer Hospital
Taiyuan, China, 030013
Actively Recruiting
14
Taizhou Hospital of Zhejiang Province
Taizhou, China, 317000
Actively Recruiting
15
Weifang People's Hospital
Weifang, China, 261041
Actively Recruiting
16
Hubei Cancer Hospital
Wuhan, China, 430079
Actively Recruiting
17
Subei People's Hospital of Jiangsu province
Yangzhou, China, 225001
Actively Recruiting
Research Team
R
Reference Study ID Number: ML46361 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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