Not yet recruiting NCT07543250
A Real-World Study of Inavolisib in Patients With HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inavolisib in Combination With ET, Inavolisib in Combination With ET+CDK4/6i.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
A Multicenter, Observational Study on the Real-World Effectiveness and Safety of inavolisib Combined with Endocrine Therapy With or Without a CDK4/6 Inhibitor in Patients with HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer.
Interventions
- Drug Inavolisib in Combination With ET
Inavolisib in Combination With ET - Drug Inavolisib in Combination With ET+CDK4/6i
Inavolisib in Combination With ET+CDK4/6i
Primary outcome measures
- Real-World Progression-Free Survival (rwPFS) [Time frame: From first prescription of inavolisib to disease progression or death from any cause, assessed for up to approximately 3 years]
Secondary outcome measures (3)
- Stratified rwPFS for Cohort A and Cohort B [Time frame: From first prescription of inavolisib to disease progression or death from any cause, assessed for up to approximately 3 years]
- Number of Participants With Adverse Events (AEs) [Time frame: Up to approximately 36 months]
- Real-world Duration of Response (rwDoR) [Time frame: From onset of first tumor response to first occurrence of PD or death from any cause (up to approximately 36 months)]
Eligibility criteria
Inclusion criteria
- Histologically or cytologically confirmed HR+/HER2- recurrent or metastatic breast cancer.
- Presence of a pathogenic PIK3CA mutation confirmed by tissue or plasma-based NGS/PCR testing.
- Availability of traceable electronic medical records, imaging, laboratory, and follow-up data at baseline.
- Initiated treatment with "Inavolisib + Endocrine Therapy" with or without a CDK4/6 inhibitor in real-world clinical practice, with complete and traceable regimen information.
- Provision of informed consent for this non-interventional study (if required by the center's ethics committee).
Exclusion criteria
- Concurrent participation in any interventional clinical trial at enrollment.
- Presence of another active malignancy requiring concurrent systemic therapy, or missing core data preventing outcome assessment.
- Any condition (psychiatric, social, geographical) that would preclude adequate follow-up, as judged by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Turner NC, Im SA, Saura C, Juric D, Loibl S, Kalinsky K, Schmid P, Loi S, Sunpaweravong P, Musolino A, Li H, Zhang Q, Nowecki Z, Leung R, Thanopoulou E, Shankar N, Lei G, Stout TJ, Hutchinson KE, Schutzman JL, Song C, Jhaveri KL. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2024 Oct 31;391(17):1584-1596. doi: 10.1056/NEJMoa2404625. PMID 39476340
- Jhaveri KL, Im SA, Saura C, Loibl S, Kalinsky K, Schmid P, Loi S, Thanopoulou E, Shankar N, Jin Y, Stout TJ, Clark TD, Song C, Juric D, Turner NC. Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2025 Jul 10;393(2):151-161. doi: 10.1056/NEJMoa2501796. Epub 2025 May 31. PMID 40454641
- Zhu R, Zhang H, Zhang F. Mechanistic optimization of inavolisib combined with CDK4/6 inhibitors in the treatment of PIK3CA-mutated breast tumors. Front Immunol. 2025 Nov 6;16:1693927. doi: 10.3389/fimmu.2025.1693927. eCollection 2025. PMID 41280894
Identifiers
NCT: NCT07543250 · InavoRWS