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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| inavolisib+ET |
| ||
| Inavolisib+CDK4/6i+ET |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inavolisib in Combination With ET | Drug | Inavolisib in Combination With ET |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Stratified rwPFS for Cohort A and Cohort B | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| liang Xu | Contact | 13691534938 | liangxu15@outlook.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39476340 | Result | 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. | |
| 40454641 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000723546 | inavolisib |
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| Inavolisib in Combination With ET+CDK4/6i |
| Drug |
Inavolisib in Combination With ET+CDK4/6i |
|
| 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) |
| 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. |
| 41280894 | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |