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

NCT07092254 | Active Not Recruiting

• 1 other identifier: DS1062-0007-NIS-EPI
• Study Type: observational
• Target: 760
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Triple Negative Breast Cancer

Keywords

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (6)

• Treatment sequencing before the diagnosis of advanced, metastatic TNBC (i.e., all treatments received for early TNBC if initially diagnosed with earlier-stage disease)

  Treatment sequencing Includes broad categories for surgery, radiotherapy, adjuvant and neoadjuvant chemotherapy, immunotherapy, and start and stop dates of systemic therapy.

  From date of initial diagnosis of early TNBC (if applicable) until diagnosis date of advanced, metastatic TNBC, up to approximately 15 months

• Treatment sequencing on or after the diagnosis date for advanced, metastatic TNBC

  Treatment sequencing Includes broad categories for surgery, radiotherapy, adjuvant and neoadjuvant chemotherapy, immunotherapy, and start and stop dates of systemic therapy.

  From date of initial diagnosis of advanced, metastatic TNBC until end of follow-up, up to approximately 15 months

• Real-world disease-free interval (rwDFI)

  Real-world disease-free interval (rwDFI) is assessed from the completion of treatment with curative intent (either date of primary breast tumor surgery or date of last dose of systemic anticancer therapy \[not including endocrine therapy\], whichever occurred last) and the first documented local or distant disease recurrence date

  From the completion of treatment with curative intent (either date of breast tumor surgery or date of last dose of systemic therapy (whichever occurred last) and the first local or distant disease recurrence date, up to approximately 15 months

• Clinician-defined real-world progression-free survival (rwPFS)

  Clinician-defined rwPFS is assessed from the index date and from the start of each line of therapy.

  From the start of each line of therapy until end of follow up, up to approximately 15 months

• Overall survival

  OS is assessed from the index date and from the start of each line of therapy.

  From the start of each line of therapy until end of follow-up, up to approximately 15 months

• Occurrence of clinical events of interest

  The occurrence of the following clinical events of interest will be assessed during each therapy line: Oral mucositis/stomatitis, Interstitial lung disease/pneumonitis, OSE, Diarrhea, Nausea/vomiting, Anemia, Neutropenia, Febrile neutropenia, Leukopenia, Lymphopenia, Thrombocytopenia.

  From the start of each line of therapy until end of follow-up, up to approximately 15 months

Study Arms (1)

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.

Drug: No drug

Interventions

No drug DRUG

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

Advanced/metastatic TNBC

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 study population will consist of adult patients residing in Canada, France, Spain, and the United Kingdom who received a diagnosis of hormone receptor (HR)-negative and HER2-negative advanced/metastatic TNBC any time from 1 January 2020 to 31 March 2024.

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (1)

Research Site

Basking Ridge, New Jersey, 07920, United States

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Director

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 29, 2025
• Study Start: September 1, 2025
• Primary Completion: November 28, 2025
• Study Completion (Estimated): June 12, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)