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

NCT07543250 | Not Yet Recruiting FDA Drug

• 1 other identifier: InavoRWS
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Breast Cancer

Keywords

PIK3CA mutation; breast cancer

Outcome Measures

Primary Outcomes (1)

• Real-World Progression-Free Survival (rwPFS)

  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.

  From first prescription of inavolisib to disease progression or death from any cause, assessed for up to approximately 3 years

Secondary Outcomes (3)

• Stratified rwPFS for Cohort A and Cohort B

  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)

  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)

Study Arms (2)

inavolisib+ET

Drug: Inavolisib in Combination With ET

Inavolisib+CDK4/6i+ET

Drug: Inavolisib in Combination With ET+CDK4/6i

Interventions

Inavolisib in Combination With ET DRUG

Inavolisib in Combination With ET

inavolisib+ET

Inavolisib in Combination With ET+CDK4/6i DRUG

Inavolisib in Combination With ET+CDK4/6i

Inavolisib+CDK4/6i+ET

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• xuliang: lead

Related Publications (3)

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

inavolisib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

liang Xu

CONTACT

13691534938; liangxu15@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 21, 2026
• Study Start (Estimated): May 16, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share