Phase 3 EMBRACA trial results reveal patients with HER2-negative, locally advanced or metastatic breast cancer harboring germline BRCA (gBRCA) mutations treated with talazoparib, displayed clinical benefit in both a real-world analyses and phase 3 EMBRACA trial, presented at the 39th Annual Miami Breast Cancer Conference. 

“While the (real-world) study sample size was limited, the potentially eligible patient population is considered to be rare, given the fact that gBRCA mutations are detected in less than 5% of unselected patients with metastatic breast cancer, and gBRCA mutation testing is not universally performed,” stated lead study author Reshma L. Mahtani, DO, Miami Cancer Institute at Baptist Health South Florida, alongside fellow colleagues.

With respect to past studies having analyzed patient characteristics, treatment patterns, and outcomes in patients who have received talazoparib in the real-world setting in France, Turkey, and Russia, investigators acknowledged the lack of said data representation in clinical practice in the United States. This said, investigators sought to collect this information in adult patients with HER2-negative, locally advanced or metastatic breast cancer harboring gBRCA mutations who were administered talazoparib as a form of therapy in the United States.

The EMBRACA trial consisted of 84 patients who have received talazoparib monotherapy initiated on or after October 16, 2018. Additionally, a 6 month minimum of follow-up time following treatment with talazoparib was required. To note, the median age at the time of talazoparib initiation was 62 years (range, 36-91), 98% were female, and 71% were White. Patients received talazoparib in various lines of treatment; specifically, 14% received it in the first line, 41% in the second line, 35% received it in the third line, and 11% received it in the fourth line.

Investigators utilized descriptive statistics to report demographic and clinical characteristics, as well as treatment patterns and clinical outcomes. it has been confirmed the Kaplan-Meier method was leveraged to describe time-to-event outcomes.

"Results revealed a median of 8.2 months of follow-up from the talazoparib initiation in all patients included in the real-world study (n = 84), the median progression-free survival (PFS) was 8.7 months (95% CI, 8.0-9.9), the overall tumor response rate (ORR) was 63% (95% CI, 52%-74%), and the median time to treatment failure (TTF) was 8.6 months (95% CI, 8.0-9.7). Similar outcomes were noted in the subsets of patients with hormone receptor–positive disease, and those with triple-negative breast cancer (TNBC)", investigators continued to reveal.

“Treatment and testing patterns may not reflect those of all oncologists managing patients with locally advanced or metastatic breast cancer,” investigators concluded.