Clinical trial NCT04987931: Real-World Outcomes of US Talazoparib-Treated Patients With Locally Advanced or Metastatic Breast Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Talazoparib
Breast Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-08-03
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to Treatment Failure (TTF) for Talazoparib
timeFrame: 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:
measure: Real-World Progression Free Survival (rwPFS) From Initiation of Talazoparib
timeFrame: 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)
measure: Time From Initiation of Talazoparib to Initiation of Subsequent Chemotherapy
timeFrame: 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)
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer Inc
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: