Real-World Outcomes of US Talazoparib-Treated Patients With Locally Advanced or Metastatic Breast Cancer

Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes Among Talazoparib-Treated Patients With HER2-Negative, Locally Advanced or Metastatic Breast Cancer and Germline BRCA1/2 Mutations: US Chart Review

This study is a retrospective, multi-site, patient-level medical chart review of US adult patients with locally advanced or metastatic breast cancer (ABC) who initiated talazoparib on or after October 16, 2018 and were managed by participating providers from Cardinal Health's Oncology Provider Extended Network (OPEN).

This study will describe patient characteristics, treatment patterns, and clinical outcomes of talazoparib-treated patients in real-world practice setting in US.

The primary population for this study includes:

-HER2-negative ABC patients with germline BRCA1/2 (gBRCA1/2) mutations treated with talazoparib monotherapy initiated on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Talazoparib

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • Pfizer Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The primary population for this study includes:

-HER2-negative ABC patients with germline BRCA1/2 (gBRCA1/2) mutations treated with talazoparib monotherapy initiated on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib.

Description

Inclusion Criteria:

• Diagnosed with HER2-negative ABC
• gBRCA1/2 mutation(s)

• Treatment with talazoparib monotherapy initiated on or after October 16, 2018

  -≥18 years of age at initiation of talazoparib

• A minimum of 6 months follow-up time after initiation of talazoparib unless the patient died within this follow-up period

Exclusion Criteria:

• Participation in any BC clinical trial after initiation of talazoparib
• Treatment with a PARP inhibitor as neoadjuvant/adjuvant therapy
• gBRCA1/2 or HER2 status unknown
• Diagnosis of any other malignancy, except carcinoma in situ or nonmelanoma skin cancer, within the 5 years prior to data collection

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary population: Talazoparib-treated patients with HER2- ABC with gBRCA1/2m; HER2-negative ABC patients with gBRCA1/2 mutations treated with talazoparib monotherapy initiated on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib.	Drug: Talazoparib; This retrospective chart review study focuses on patients with HER2- ABC with gBRCA1/2m initiating talazoparib on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib.; Other Names: TALZENNA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Treatment Failure (TTF) for Talazoparib	TTF was defined as the time from initiation of talazoparib to discontinuation for any reason, which included disease progression, treatment toxicity, and death. Index date was defined as the date of initiation of talazoparib on or after 16-October-2018. Median was analyzed using the Kaplan-Meier method.	Index date up to talazoparib discontinuation, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real-World Progression Free Survival (rwPFS) From Initiation of Talazoparib	rwPFS was defined as the time from initiation of talazoparib to charted disease progression based on radiographic imaging or death from any cause, whichever occurred first. Index date was defined as the date of initiation of talazoparib on or after 16-October-2018. Since information was retrieved from participants' charts, there was no specific criteria for progression. It was determined on physician judgement. Median was analyzed using the Kaplan-Meier method.	Index date up to charted disease progression, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study)
Time From Initiation of Talazoparib to Initiation of Subsequent Chemotherapy	The time taken for initiating subsequent chemotherapy after initiation of talazoparib was reported in this outcome measure. Index date was defined as the date of initiation of talazoparib on or after 16-October-2018. Median was analyzed using the Kaplan-Meier method.	Index date up to initiation of subsequent chemotherapy, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2021
• Primary Completion (Actual): October 11, 2021
• Study Completion (Actual): October 11, 2021

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: July 23, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Breast Cancer; Talazoparib
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; Talazoparib
• Other Study ID Numbers: C3441053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No