Clinical and Therapeutic Outcomes by Molecular Subtype in Breast Cancer

September 28, 2026 updated by: Erick Andres Cantor Rizo, Fundación Santa Fe de Bogota

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
370

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Colombia
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia
        • Recruiting
        • Hospital Universitario Fundación Santa Fe de Bogotá

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: RETROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Luminal A
Drug: 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.

Other Names:
  • Palbociclib
  • Ribociclib
  • Abemaciclib
Other: 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.
Luminal B HER2-Negative
Drug: 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.

Other Names:
  • Palbociclib
  • Ribociclib
  • Abemaciclib
Other: 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.
Luminal B HER2-Positive
Other: 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.

Drug: 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.

Other Names:
  • Pertuzumab
  • Trastuzumab
  • Trastuzumab Emtansine
HER2-Enriched
Other: 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.

Drug: 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.

Other Names:
  • Pertuzumab
  • Trastuzumab
  • Trastuzumab Emtansine
Triple-Negative
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
From diagnosis until death from any cause or last follow-up, assessed up to approximately 12 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación Santa Fe de Bogota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erick Andrés Cantor Rizo, MD, Fundación Santa Fe de Bogotá

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCEI-18860-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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