Clinical and Therapeutic Outcomes by Molecular Subtype in Breast Cancer

NCT07856225 | Recruiting

• 1 other identifier: CCEI-18860-2025
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms; HER2-Positive Breast Cancer; Hormone Receptor-Positive Breast Cancer

Keywords

Molecular Subtype; Luminal A; Luminal B; HER2-Enriched; Triple-Negative; HER2-Low; Ki-67; CDK4/6 Inhibitors; Anti-HER2 Therapy; COVID-19; Health Insurance; Cost of Illness; Micro-Costing; Colombia

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  From diagnosis until death from any cause or last follow-up, assessed up to approximately 12 years

Secondary Outcomes (5)

• Progression-Free Survival

  From diagnosis until progression, death or last follow-up, assessed up to approximately 12 years

• Tumor Recurrence

  From completion of curative-intent treatment until recurrence or last follow-up, assessed up to approximately 12 years

• Treatment Response

  At the end of each treatment line (neoadjuvant, adjuvant or systemic therapy), assessed up to approximately 12 years

• Incidence of Grade 3-4 Adverse Events

  From treatment start until end of follow-up, assessed up to approximately 12 years

• Direct Medical Costs of Breast Cancer Care

  Full care trajectory from diagnosis through follow-up, with a 3% annual discount rate for horizons longer than 1 year

Study Arms (5)

Luminal A

Drug: CDK4/6 Inhibitors; Other: Standard Breast Cancer Treatment

Luminal B HER2-Negative

Drug: CDK4/6 Inhibitors; Other: Standard Breast Cancer Treatment

Luminal B HER2-Positive

Drug: Anti-HER2 Therapy; Other: Standard Breast Cancer Treatment

HER2-Enriched

Drug: Anti-HER2 Therapy; Other: Standard Breast Cancer Treatment

Triple-Negative

Other: Standard Breast Cancer Treatment

Interventions

CDK4/6 Inhibitors DRUG

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.

Also known as: Palbociclib, Ribociclib, Abemaciclib

Luminal A; Luminal B HER2-Negative

Anti-HER2 Therapy DRUG

HER2-targeted therapy (such as trastuzumab, pertuzumab or trastuzumab emtansine) administered in routine clinical practice. The study does not assign or modify treatment.

Also known as: Trastuzumab, Pertuzumab, Trastuzumab Emtansine

HER2-Enriched; Luminal B HER2-Positive

Standard Breast Cancer Treatment OTHER

Surgery, radiotherapy, chemotherapy, endocrine therapy and other systemic therapies administered according to routine clinical practice. The study does not assign or modify treatment.

HER2-Enriched; Luminal A; Luminal B HER2-Negative; Luminal B HER2-Positive; Triple-Negative

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

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Santa Fe de Bogota: lead

Study Sites (1)

Hospital Universitario Fundación Santa Fe de Bogotá

Bogotá, Bogota D.C., Colombia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms; COVID-19

Interventions

palbociclib; ribociclib; abemaciclib; Trastuzumab; pertuzumab; Ado-Trastuzumab Emtansine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Maytansine; Macrolides; Lactones; Organic Chemicals; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Erick Andrés Cantor Rizo, MD

  Fundación Santa Fe de Bogotá

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erick Andrés Cantor Rizo, MD

CONTACT

+57 601 6030303; erick.cantor@fsfb.org.co

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Hematologist and Clinical Oncologist

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)