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

NCT05141708 | Completed Results FDA Drug

• 1 other identifier: C3441055
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Breast Cancer; Breast Neoplasms

Keywords

Metastatic Breast Cancer; Breast Neoplasms

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. 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.

  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

Study Arms (1)

Talazoparib-treated adults with HER2- gBRCAm mBC

Adult patients with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations who initiated talazoparib treatment in first-line or later line of therapy between January 1, 2018 and September 30, 2020.

Drug: Talazoparib

Interventions

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

Also known as: Talzenna

Talazoparib-treated adults with HER2- gBRCAm mBC

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

Adult patients with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations who initiated talazoparib treatment in first-line or later line of therapy between January 1, 2018 and September 30, 2020 identified from Flatiron Health Analytic Database.

You may qualify if:

• 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

You may not qualify if:

• 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

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: November 19, 2021
• First Posted: December 2, 2021
• Study Start: December 17, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 16, 2024
• Results First Posted: February 16, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)