Clinical trial · Observational
A Real-World Study of Inavolisib in Patients With HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer
NCT07543250CI-TRIAL-00108874not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inavolisib in Combination With ET | Drug | — | UNRESOLVED |
| Inavolisib in Combination With ET+CDK4/6i | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- inavolisib+ET
- interventionNames
- Drug: Inavolisib in Combination With ET
- label
- Inavolisib+CDK4/6i+ET
- interventionNames
- Drug: Inavolisib in Combination With ET+CDK4/6i
Primary outcomes (1)
- measure
- Real-World Progression-Free Survival (rwPFS)
- timeFrame
- From first prescription of inavolisib to disease progression or death from any cause, assessed for up to approximately 3 years
- description
- Time from the index date (first prescription of inavolisib) to the first recorded disease progression (based on radiological or clinical assessment) or death from any cause, whichever occurs first.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- RESULTTurner 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
- RESULTJhaveri 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
- RESULTZhu 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