A Real-World Study of Inavolisib in Patients With HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer

Обзор

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.

Вмешательства

• Препарат Inavolisib in Combination With ET
  Inavolisib in Combination With ET
• Препарат Inavolisib in Combination With ET+CDK4/6i
  Inavolisib in Combination With ET+CDK4/6i

Первичные конечные точки

• Real-World Progression-Free Survival (rwPFS) [Срок оценки: From first prescription of inavolisib to disease progression or death from any cause, assessed for up to approximately 3 years]

Вторичные конечные точки (3)

• Stratified rwPFS for Cohort A and Cohort B [Срок оценки: 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) [Срок оценки: Up to approximately 36 months]
• Real-world Duration of Response (rwDoR) [Срок оценки: From onset of first tumor response to first occurrence of PD or death from any cause (up to approximately 36 months)]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT07543250 · InavoRWS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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