NCT05141708

Treatment Patterns and Clinical Outcomes Among Talazoparib-Treated Adults With HER2-Negative mBC With gBRCA1/2m

Completed Results posted Last updated 16 February 2024

What this trial tests

trial testing Talazoparib in Metastatic Breast Cancer in 33 participants. Completed in 30 June 2022.

Timeline

17 December 2021

Primary endpoint
30 June 2022

30 June 2022

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	33
Start date	17 December 2021
Primary completion	30 June 2022
Estimated completion	30 June 2022
Sites	1 location across United States

Drugs / interventions tested

• Talazoparib (talazoparib) — full drug profile →

Conditions studied

• Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →
• Breast Neoplasms — all drugs for Breast Neoplasms →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Metastatic Breast Cancer or Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Treatment Failure (TTF) for Talazoparib Primary · Index date up to talazoparib discontinuation or at the end of follow-up or date of data cut-off (30-September-2020), maximum up to approximately 2.9 years; data retrieved and studied approximately 6.14 months of this study

TTF was defined as the time from initiation of talazoparib to discontinuation for any reason, which included disease progression, treatment toxicity, and death. Participants who were still on therapy at the end of follow-up (earliest of last participant-level structured or abstracted activity \[i.e., the last record of participant vitals, medication administrations, or reported laboratory tests/results, or abstracted end date of oral medications\] or date of data cut-off \[30 September 2020\]) were censored. Index date was defined as the date first talazoparib-containing line of therapy betwee

Group	Value	95% CI
Talazoparib	5.5	2.1 – 10.5

Sponsor's own description

This non-interventional retrospective study will describe real-world treatment patterns and clinical outcomes among adults with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations who initiated talazoparib as a first or later line of therapy. Patients will be identified from the Flatiron Electronic Health Record database.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Landscape of germline cancer predisposition mutations testing and management in pediatrics: Implications for research and clinical care.
   Shahani SA, Marcotte EL. · · 2022 · cited 11× · PMID 36225340 · DOI 10.3389/fped.2022.1011873