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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Breast cancer is the most frequent malignancy in women, with an estimated 2.3 million new cases and 685,000 deaths worldwide in 2020. Molecular subtypes defined by hormone receptor, HER2 and Ki-67 status guide treatment and prognosis. Colombian studies have described the distribution of molecular subtypes, but no study has integrated clinical, molecular, treatment and contextual factors (such as the COVID-19 pandemic and health insurance regimen) in a single cohort, and cost data disaggregated by stage and phase of care are scarce.
Design: Single-center, observational, retrospective cohort study with an umbrella design that will support subtype-specific and treatment-specific secondary analyses, plus an economic component (cost-of-illness study with a micro-costing approach from the perspective of the Colombian health system).
Population: Women 18 years or older with histologically confirmed breast cancer and documented molecular subtype determined by immunohistochemistry and/or in situ hybridization, treated and/or followed at Fundación Santa Fe de Bogotá between January 1, 2014 and December 31, 2024. The sample size (370 patients) was calculated to estimate a 10% proportion of triple-negative breast cancer with 95% confidence and 3% precision.
Subtype-specific objectives: (1) triple-negative disease: pathological response, adverse events, recurrence, progression and survival, including the impact of the COVID-19 pandemic (diagnosis before versus after March 2020) and the influence of health insurance regimen; (2) luminal A disease: treatment patterns and outcomes, including high-risk patients who were candidates for abemaciclib or ribociclib; (3) luminal B HER2-positive disease: association of anti-HER2 therapy with pathological complete response, recurrence and survival; (4) luminal B HER2-negative disease: association of high Ki-67 with adjuvant or neoadjuvant chemotherapy decisions and outcomes; (5) HER2-enriched disease: anti-HER2 therapy, response, recurrence, survival and adverse events; (6) hormone receptor-positive/HER2-negative disease: outcomes with versus without CDK4/6 inhibitors; (7) HER2-low disease: recurrence and associated factors; and (8) direct medical costs by clinical stage and phase of care.
Data collection: Data will be abstracted from institutional records (clinical databases, pathology reports, electronic medical records and oncology follow-up records) into a REDCap database with access restricted to the research team. Variables include demographics, body mass index, menopausal status, histology, molecular subtype and biomarkers (hormone receptors, HER2, Ki-67), stage and metastatic sites, comorbidities (Charlson index), performance status, treatments (surgery, radiotherapy, endocrine therapy, chemotherapy, anti-HER2 therapy, CDK4/6 inhibitors and other systemic therapies), dates of diagnosis, progression, recurrence and death, and health insurance regimen. For the economic component, resource use will be identified for case types by clinical stage, therapeutic subtype and phase of care, coded with CUPS and CUM codes and valued with national cost and price sources.
Statistical analysis: Descriptive statistics will be used for the cohort. Bivariate associations will be assessed with chi-square or Fisher exact tests and t or Mann-Whitney tests. Overall survival, progression-free survival and time to recurrence will be analyzed with Kaplan-Meier curves and log-rank tests, followed by multivariable Cox regression adjusted for age, stage, comorbidities, treatment, insurance regimen and year of diagnosis, with verification of the proportional hazards assumption. Dichotomous outcomes (pathological complete response, grade 3-4 adverse events) will be analyzed with logistic regression. Interaction terms (for example, subtype by COVID-19 period) will be explored, the 10 events-per-variable rule will be applied, and collinearity will be assessed with the variance inflation factor. Missing data will be handled with multiple imputation when compatible with missing at random, or with sensitivity analyses otherwise. Costs will be presented by stage, therapeutic subtype and phase of care, with a 3% annual discount rate for horizons longer than one year and deterministic sensitivity analyses. Analyses will be performed in R.
Ethics: The study is classified as research without risk under Colombian Resolution 8430 of 1993 (retrospective documentary research), and additional informed consent is not required. The protocol (version 1.2) was approved by the Comité Corporativo de Ética en Investigación of Fundación Santa Fe de Bogotá (CCEI-18860-2025), and amendment version 2.0 (May 14, 2026) was approved in June 2026 (CCEI-20040-2026).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Erick Andrés Cantor Rizo, MD
- Phone Number: +57 601 6030303
- Email: erick.cantor@fsfb.org.co
Study Locations
-
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Bogota D.C.
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Bogotá, Bogota D.C., Colombia
- Recruiting
- Hospital Universitario Fundación Santa Fe de Bogotá
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: RETROSPECTIVE
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Luminal A
|
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.
Other Names:
Surgery, radiotherapy, chemotherapy, endocrine therapy and other systemic therapies administered according to routine clinical practice. The study does not assign or modify treatment. |
|
Luminal B HER2-Negative
|
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.
Other Names:
Surgery, radiotherapy, chemotherapy, endocrine therapy and other systemic therapies administered according to routine clinical practice. The study does not assign or modify treatment. |
|
Luminal B HER2-Positive
|
Surgery, radiotherapy, chemotherapy, endocrine therapy and other systemic therapies administered according to routine clinical practice. The study does not assign or modify treatment. HER2-targeted therapy (such as trastuzumab, pertuzumab or trastuzumab emtansine) administered in routine clinical practice. The study does not assign or modify treatment.
Other Names:
|
|
HER2-Enriched
|
Surgery, radiotherapy, chemotherapy, endocrine therapy and other systemic therapies administered according to routine clinical practice. The study does not assign or modify treatment. HER2-targeted therapy (such as trastuzumab, pertuzumab or trastuzumab emtansine) administered in routine clinical practice. The study does not assign or modify treatment.
Other Names:
|
|
Triple-Negative
|
Surgery, radiotherapy, chemotherapy, endocrine therapy and other systemic therapies administered according to routine clinical practice. The study does not assign or modify treatment. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall Survival
Time Frame: From diagnosis until death from any cause or last follow-up, assessed up to approximately 12 years
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From diagnosis until death from any cause or last follow-up, assessed up to approximately 12 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Progression-Free Survival
Time Frame: From diagnosis until progression, death or last follow-up, assessed up to approximately 12 years
|
From diagnosis until progression, death or last follow-up, assessed up to approximately 12 years
|
|
Tumor Recurrence
Time Frame: From completion of curative-intent treatment until recurrence or last follow-up, assessed up to approximately 12 years
|
From completion of curative-intent treatment until recurrence or last follow-up, assessed up to approximately 12 years
|
|
Treatment Response
Time Frame: At the end of each treatment line (neoadjuvant, adjuvant or systemic therapy), assessed up to approximately 12 years
|
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
Time Frame: From treatment start until end of follow-up, assessed up to approximately 12 years
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From treatment start until end of follow-up, assessed up to approximately 12 years
|
|
Direct Medical Costs of Breast Cancer Care
Time Frame: Full care trajectory from diagnosis through follow-up, with a 3% annual discount rate for horizons longer than 1 year
|
Full care trajectory from diagnosis through follow-up, with a 3% annual discount rate for horizons longer than 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Erick Andrés Cantor Rizo, MD, Fundación Santa Fe de Bogotá
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Skin Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Breast Diseases
- Skin and Connective Tissue Diseases
- COVID-19
- Breast Neoplasms
- Triple Negative Breast Neoplasms
- Amino Acids, Peptides, and Proteins
- Proteins
- Organic Chemicals
- Polycyclic Compounds
- Antibodies, Monoclonal, Humanized
- Antibodies, Monoclonal
- Antibodies
- Immunoglobulins
- Immunoproteins
- Blood Proteins
- Serum Globulins
- Globulins
- Macrolides
- Lactones
- Lactams, Macrocyclic
- Macrocyclic Compounds
- Maytansine
- Trastuzumab
- Ado-Trastuzumab Emtansine
- abemaciclib
- pertuzumab
- ribociclib
- palbociclib
Other Study ID Numbers
- CCEI-18860-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Individual participant data will not be shared. Data are obtained from a retrospective review of medical records without additional informed consent and are protected under Colombian personal data protection law (Law 1581 of 2012). Aggregated results will be published in peer-reviewed journals.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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