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

Breast Neoplasms Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05141708
• Other study ID #: C3441055
• Status: Completed
• Start date: December 17, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Talazoparib
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

Locations

Country	Name	City	State
United States	Pfizer Inc.	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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