Actively Recruiting
A Non-interventional Study to Evaluate the Effectiveness and Safety of Inavolisib in Patients With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
Led by Hoffmann-La Roche · Updated on 2026-05-18
500
Participants Needed
22
Research Sites
36 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of inavolisib-based treatment in people with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer that is resistant to endocrine therapy. This study focuses on patients with a specific genetic mutation called PIK3CA, who have either relapsed or progressed after completing adjuvant endocrine therapy. The research is conducted in China to observe real-world outcomes in routine clinical practice. Participants in this observational study receive inavolisib treatment as determined by their physicians, following local clinical guidelines. Other treatments such as palbociclib and fulvestrant may also be administered based on physician discretion and local labeling. The study does not interfere with treatment decisions but monitors the effectiveness and safety of inavolisib over time. During the study, researchers will track various outcomes including progression-free survival, time to disease progression, tumor response, duration of response, and treatment duration for up to approximately 36 months. Safety is monitored by recording adverse events and any dose modifications. Participants' experiences with inavolisib, including treatment discontinuation and subsequent therapies, are also observed to assess real-world treatment patterns and outcomes.
CONDITIONS
Brief 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...
- Diagnosed with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer following recurrence on or after completing adjuvant endocrine therapy
- Receiving inavolisib treatment for the first time
- PIK3CA mutation confirmed by an approved test using blood or tumor tissue prior to starting inavolisib
You will not qualify if you...
- Treatment with inavolisib is not indicated as per prescribing information
- Not receiving inavolisib treatment according to standard of care and local labeling
- Started palbociclib and fulvestrant before inavolisib without proper timing of PIK3CA mutation testing
- Any reason determined by the investigator that makes the participant difficult to follow up or unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 36 months
Participants receive inavolisib treatment as prescribed by their physician according to local clinical practice and labeling. The treatment aims to evaluate effectiveness and safety in endocrine-resistant breast cancer.
Visits occur as per routine clinical practice during treatment
Duration - Up to approximately 36 months
Participants are monitored for disease progression, response to treatment, and safety outcomes after starting inavolisib.
Follow-up visits occur according to clinical routine up to 36 months
Trial Site Locations
Total: 22 locations
1
Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine)
Lanzhou, Gansu, China, 730050
Actively Recruiting
2
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
3
Wenzhou Medical University Affiliated Second Hospital
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
4
Peking University First Hospital
Beijing, China, 100034
Actively Recruiting
5
Peking University Third Hospital
Beijing, China, 100191
Actively Recruiting
6
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, China, 610072
Actively Recruiting
7
Chongqing Cancer Hospital
Chongqing, China, 400030
Actively Recruiting
8
Zhujiang Hospital, Southern Medical University
Guangzhou, China, 510280
Actively Recruiting
9
Guizhou Provincial People's Hospital
Guiyang, China, 550002
Actively Recruiting
10
Hainan Provincial Peoples Hospital
Haikou, China, 570311
Actively Recruiting
11
Harbin Medical University Cancer Hospital
Harbin, China, 150081
Actively Recruiting
12
The First Affiliated Hospital of Anhui Medical University
Hefei, China, 230022
Actively Recruiting
13
Shandong Provincial Hospital
Jinan, China, 250021
Actively Recruiting
14
Jiangxi Cancer Hospital
Nanchang, China, 330006
Actively Recruiting
15
Jiangsu Province Hospital
Nanjing, China, 210029
Actively Recruiting
16
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
17
Shanxi Provincial Cancer Hospital
Taiyuan, China, 030013
Actively Recruiting
18
Taizhou Hospital of Zhejiang Province
Taizhou, China, 317000
Actively Recruiting
19
Weifang People's Hospital
Weifang, China, 261041
Actively Recruiting
20
Hubei Cancer Hospital
Wuhan, China, 430079
Actively Recruiting
21
The First Affiliated Hospital of Xian Jiao Tong University
Xi'an, China
Actively Recruiting
22
Subei People's Hospital of Jiangsu province
Yangzhou, China, 225001
Actively Recruiting
Research Team
R
Reference Study ID Number: ML46361 https://forpatients.roche.com/
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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