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

Daiichi Sankyo

Status: Not yet enrolling

Conditions: Triple Negative Breast Cancer

Treatments: Drug: No drug

Study type: Observational

Funder types: Industry

Identifiers

NCT07092254

DS1062-0007-NIS-EPI

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 760 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patients meeting the following criteria will be included in the study:

• Histologically or cytologically documented diagnosis of HR-negative and HER2-negative locally recurrent inoperable TNBC (i.e., cannot be treated with curative intent) or advanced/metastatic TNBC from 1 January 2020 to 31 March 2024

  • Negative for estrogen receptor with < 1% of tumor cells positive for estrogen receptor (ER) on immunohistochemistry (IHC)
  • Negative for progesterone receptor with < 1% of tumor cells positive for progesterone receptor on IHC
  • Negative for HER2 with 0 or 1+ intensity on IHC or 2+ intensity on IHC and negative by in situ hybridization per the American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) HER2 guideline
  • The test documented closest to the diagnosis date should be used as the reference

• Aged at least 18 years upon diagnosis of advanced/metastatic TNBC

• Known vital status (alive or deceased) as of last available follow-up date documented within the medical record

Patients meeting any of the following exclusion criteria will not be eligible for the study:

• 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

Trial design

760 participants in 1 patient group

Advanced/metastatic TNBC

Description:

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.

Treatment:

Drug: No drug