About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients older than 18 years with a histopathologically confirmed diagnosis of breast cancer.
Treated at Fundación Santa Fe de Bogotá between January 1, 2014 and December 31, 2024.
Available record of the tumor molecular subtype (luminal A, luminal B HER2-negative, luminal B HER2-positive, HER2-enriched or triple-negative), determined by immunohistochemistry and/or in situ hybridization.
Disqualifiers
Metastatic tumors from another primary site involving the breast (for example, breast metastases from another primary tumor).
Lesions of uncertain malignant potential or in situ tumors.
Incomplete or missing information on molecular subtype, treatment received or clinical outcomes.
Oncology follow-up outside the institution without adequate traceability of clinical outcomes.
Trial population
Women 18 years or older with histologically confirmed breast cancer and a documented molecular subtype who were treated and/or followed at Hospital Universitario Fundación Santa Fe de Bogotá (Bogotá, Colombia) between January 1, 2014 and December 31, 2024, identified through institutional clinical databases, pathology reports and oncology follow-up records.
Trial design
Cohort
Retrospective
Treatments tested in this trial
CDK4/6 Inhibitors
DrugCDK4/6 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
DrugHER2-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
Other interventionSurgery, radiotherapy, chemotherapy, endocrine therapy and other systemic therapies administered according to routine clinical practice. The study does not assign or modify treatment.
Treatment groups
Trial outcomes
Primary outcomes
Overall Survival
Secondary outcomes
Progression-Free Survival
Tumor Recurrence
Treatment Response
Incidence of Grade 3-4 Adverse Events
Sponsors and contacts
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