Patterns of Care and Outcomes in Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer

NCT ID: NCT07092254

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

760 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-04-08

Brief Summary

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This transnational noninterventional study aims to gather real-world evidence on locally recurrent inoperable (hereafter referred to as advanced) or metastatic TNBC (a/m TNBC) biomarker testing, treatment patterns by line of therapy, and outcomes to contextualize findings of TROPION-Breast02 and TROPION-Breast05 in selected settings outside the United States (US), including Canada, the United Kingdom (UK), France, and Spain.

Detailed Description

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This study will document cancer characteristics, real-world cancer treatment patterns, clinical outcomes, and clinical events of interest in patients with locally recurrent inoperable or metastatic triple-negative breast cancer. No study or investigational drug will be administered in this non-interventional study; however, a retrospective review of medical records will be conducted.

Conditions

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Triple Negative Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Advanced/metastatic TNBC

Adult patients who received a diagnosis of HR-negative and HER2-negative advanced/ metastatic TNBC any time from 1 January 2020 to 31 March 2024.

No drug

Intervention Type DRUG

No study drug will be administered in this non-interventional study.

Interventions

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No drug

No study drug will be administered in this non-interventional study.

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* Diagnosis of other prior primary cancers or malignancies (except nonmelanoma skin cancer) unless curatively treated with no evidence of disease for at least 3 years before diagnosis of advanced/metastatic TNBC
* Ever received treatment as part of any clinical trial of an investigational product for cancer
* No available medical record entry in the 90 days before or after diagnosis of advanced/metastatic TNBC
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Director

Role: STUDY_DIRECTOR

Daiichi Sankyo

Central Contacts

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Daiichi Sankyo Contact for Clinical Trial Information

Role: CONTACT

908-992-6400

Other Identifiers

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DS1062-0007-NIS-EPI

Identifier Type: -

Identifier Source: org_study_id

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