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Clinical and Therapeutic Outcomes by Molecular Subtype in Breast Cancer
Sponsor: Fundación Santa Fe de Bogota
Summary
Breast cancer is the most common cancer in women worldwide. Its molecular classification, based on hormone receptors (estrogen and progesterone), HER2 and Ki-67, defines subtypes with different prognoses and treatments. In Colombia, there is limited information that integrates the clinical, treatment, sociodemographic and contextual characteristics of each subtype, and limited data on the direct medical costs of breast cancer care. This retrospective cohort study will review the medical records of women 18 years or older with biopsy-confirmed breast cancer and a documented molecular subtype who were treated at Fundación Santa Fe de Bogotá (Bogotá, Colombia) between January 1, 2014 and December 31, 2024. It will describe each molecular subtype (luminal A, luminal B HER2-negative, luminal B HER2-positive, HER2-enriched, triple-negative and HER2-low) and evaluate the association of clinical, molecular and treatment characteristics with overall survival, progression-free survival, recurrence, treatment response and grade 3-4 adverse events. It will also explore the impact of the COVID-19 pandemic and health insurance regimen on outcomes, and estimate direct medical costs of breast cancer care by clinical stage and phase of care. The investigators will not assign or modify any treatment.
Official title: Evaluation of Clinical and Therapeutic Outcomes According to Molecular Subtype in Patients With Breast Cancer: Experience of Fundación Santa Fe de Bogotá
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
370
Start Date
2025-12-01
Completion Date
2027-06-01
Last Updated
2026-10-02
Healthy Volunteers
No
Conditions
Interventions
CDK4/6 Inhibitors
CDK4/6 inhibitors (palbociclib, ribociclib or abemaciclib) combined with endocrine therapy, administered in routine clinical practice. The study does not assign or modify treatment; exposure data are abstracted retrospectively from medical records.
Anti-HER2 Therapy
HER2-targeted therapy (such as trastuzumab, pertuzumab or trastuzumab emtansine) administered in routine clinical practice. The study does not assign or modify treatment.
Standard Breast Cancer Treatment
Surgery, radiotherapy, chemotherapy, endocrine therapy and other systemic therapies administered according to routine clinical practice. The study does not assign or modify treatment.
Locations (1)
Hospital Universitario Fundación Santa Fe de Bogotá
Bogotá, Bogota D.C., Colombia