NCT07856225Recruiting
Clinical and Therapeutic Outcomes by Molecular Subtype in Breast Cancer
Evaluation of Clinical and Therapeutic Outcomes According to Molecular Subtype in Patients With Breast Cancer: Experience of Fundación Santa Fe de Bogotá
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 370 (estimated)
- First submitted
- 28 Sept 2026
- Start date
- 1 Dec 2025
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- Fundación Santa Fe de Bogota
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07856225
What you commit to
- Study type: Observational
- Planned participants: 370
- From 1 Dec 2025 to the primary completion date, 1 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Incomplete or missing information on molecular subtype, treatment received or clinical outcomes.
Other illness
- Lesions of uncertain malignant potential or in situ tumors.
Other
- Metastatic tumors from another primary site involving the breast (for example, breast metastases from another primary tumor).
- Oncology follow-up outside the institution without adequate traceability of clinical outcomes.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Fundación Santa Fe de Bogotá Coordinator of this site? Confirm its status | Bogotá | Colombia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.