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

NCT04987931 | Completed Results FDA Drug

• 1 other identifier: C3441053
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Talazoparib; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Real-World Progression Free Survival (rwPFS) From Initiation of Talazoparib

  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

  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)

Study Arms (1)

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

Interventions

Talazoparib DRUG

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.

Also known as: TALZENNA®

Primary population: Talazoparib-treated patients with HER2- ABC with gBRCA1/2m

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Inc

New York, New York, 10017, United States

Location

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

talazoparib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 3, 2021
• Study Start: August 20, 2021
• Primary Completion: October 11, 2021
• Study Completion: October 11, 2021
• Last Updated: January 22, 2024
• Results First Posted: January 22, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)