Skip to main content
OpenTrials
Completed

NCT Number: NCT05141708

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Inc.

New York, 10017, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  • Diagnosed with breast cancer (ICD-9 174.x or 175.x or ICD-10 C50x)
  • At least two visits in the Flatiron database on or after January 1, 2011
  • Pathology consistent with breast cancer
  • Has evidence of stage IV or recurrent metastatic breast cancer with a metastatic diagnosis date on or after January 1, 2011. This includes patients who were diagnosed with stage IV at diagnosis or were diagnosed with earlier stage disease, then developed a distant metastasis later on, or had recurrence of the disease via a distant metastasis
  • Confirmed receipt of talazoparib as treatment for mBC via abstraction initiated between January 1, 2018 and September 30, 2020
  • HER2 negative test result on or before the start of patient's first talazoparib-containing line of therapy, as defined by Flatiron's line of therapy rules
  • BRCA1, BRCA2, BRCA1 and BRCA2 germline mutation, or BRCA germline mutation not otherwise specified, identified on or before the start date of patient's first talazoparib-containing line of therapy, as defined by Flatiron's line of therapy business rules
  • Age 18 years or older at the time of first talazoparib-containing line of therapy

Exclusion criteria

  • Lacking relevant unstructured documents in the Flatiron database for review by the abstraction team
  • Receipt of drug as part of a clinical trial (captured in the database as "clinical study drug" without additional information about active ingredient or whether the patient received placebo), defined as any non-cancelled order, administration, or oral episode for a drug used in a clinical trial, on or prior to start of first talazoparib line of therapy, as defined by Flatiron's line of therapy business rules

Treatment and study plan

Talazoparib

Drug

Receipt of talazoparib as treatment for HER2-negative metastatic breast cancer with germline BRCA1/2 mutations anytime between January 1, 2018 and September 30, 2020

Other names: Talzenna

Primary outcomes

  1. Time to Treatment Failure (TTF) for Talazoparib

    Time frame: 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 between 01-Jan-2018 to 30-Sep-2020. Median was analyzed using the Kaplan-Meier method.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Treatment Patterns and Clinical Outcomes Among Talazoparib-Treated Adults With HER2-Negative Metastatic Breast Cancer and Germline BRCA1/2 Mutations: An Observational Study Using Flatiron Electronic Health Record (EHR) Database

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 2, 2021
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.