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
reaINAVO
A Prospective 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 (reaINAVO)
1 other identifier
observational
500
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2026
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2026
CompletedFirst Posted
Study publicly available on registry
January 16, 2026
CompletedStudy Start
First participant enrolled
January 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 9, 2029
April 20, 2026
April 1, 2026
2.9 years
January 9, 2026
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Real-world Progression-free Survival (rwPFS)
From index date (date of first prescription of inavolisib) to first occurrence of disease progression (PD)/death from any cause (up to approximately 36 months)
Secondary Outcomes (10)
Number of Participants With Adverse Events (AEs)
Up to approximately 36 months
Real-world Time to Progression (rwTTP)
From index date to first occurrence of PD (up to approximately 36 months)
Number of Participants With Real-world Tumor Response (rwTR) to the Treatment
Up to approximately 36 months
Real-world Duration of Response (rwDoR)
From onset of first tumor response to first occurrence of PD or death from any cause (up to approximately 36 months)
Real-world Time-to-treatment Discontinuation (rwTTD)
From index date to inavolisib discontinuation, new anti-cancer therapy initiation or death from any cause (up to approximately 36 months)
- +5 more secondary outcomes
Study Arms (1)
Inavolisib
Participants with endocrine-resistant, PIK3CA-mutated, HR+, HER2-, LA/mBC, following on or after completing adjuvant endocrine therapy will be observed for effectiveness and safety of inavolisib.
Interventions
Palbociclib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
Fulvestrant will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
Inavolisib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
Eligibility Criteria
Participants with endocrine-resistant, PIK3CA-mutated, HR+, HER2-, LA/mBC, following on or after completing adjuvant endocrine therapy in routine clinical practice in China.
You may qualify if:
- 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 may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine)
Lanzhou, Gansu, 730050, China
Wenzhou Medical University Affiliated Second Hospital
Wenzhou, Zhejiang, 325000, China
Peking University First Hospital
Beijing, 100034, China
Peking University Third Hospital
Beijing, 100191, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, 610072, China
Chongqing Cancer Hospital
Chongqing, 400030, China
Zhujiang Hospital, Southern Medical University
Guangzhou, 510280, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Shandong Provincial Hospital
Jinan, 250021, China
Jiangxi Cancer Hospital
Nanchang, 330006, China
Jiangsu Province Hospital
Nanjing, 210029, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Shanxi Provincial Cancer Hospital
Taiyuan, 030013, China
Taizhou Hospital of Zhejiang Province
Taizhou, 317000, China
Weifang People's Hospital
Weifang, 261041, China
Hubei Cancer Hospital
Wuhan, 430079, China
Subei People's Hospital of Jiangsu province
Yangzhou, 225001, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Central Study Contacts
Reference Study ID Number: ML46361 https://forpatients.roche.com/
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2026
First Posted
January 16, 2026
Study Start
January 21, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
September 9, 2029
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share