Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers

NCT03911973 ↗

Phase 1/2 Active not recruiting 37 enrolled Kari Wisinski Celcuity Inc · collab Pfizer · collab

NaSingle-groupOpen-labelTreatment

Summary

This study is designed to determine the RP2D of gedatolisib in combination with talazoparib and to evaluate the efficacy of this combination in advanced HER2 negative breast cancer that is triple negative or BRCA1/2 positive (deficient).

Timeline

Start: 2019-04-17
Primary completion: 2024-07
Completion: 2024-07

Outcome

Missed primary endpoint

paper did not meet the prespecified efficacy threshold for objective response rate. PMID 40471518 ↗

Publications

Phadke S, Miller KD, Shah A, Danciu OC, Chen Y, Yu M, Burkard ME, Wisinski KB. Phase I/II trial investigating gedatolisib plus talazoparib in advanced triple negative or BRCA1/2 positive, HER2 negative breast cancers. Breast Cancer Res Treat. 2025 Aug;212(3):521-530. doi: 10.1007/s10549-025-07747-x. Epub 2025 Jun 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gedatolisib	Small molecule	150 mg	Intravenous
Subject	Gedatolisib	Small molecule	180 mg	Intravenous
Subject	Talazoparib	Small molecule	0.75 mg	Oral
Subject	Talazoparib	Small molecule	1 mg	Oral