Clinical and Therapeutic Outcomes by Molecular Subtype in Breast Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundación Santa Fe de Bogota

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • 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.

  • 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.

  • Standard Breast Cancer Treatment

    Other intervention

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

Treatment groups

370 Participants
are divided into 5 treatment groups
Group A: Luminal A2 interventions
Group B: Luminal B HER2-Negative2 interventions
Group C: Luminal B HER2-Positive2 interventions
Group D: HER2-Enriched2 interventions
Group E: Triple-Negative1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival

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

Secondary outcomes

1

Progression-Free Survival

Time frame
From diagnosis until progression, death or last follow-up, assessed up to approximately 12 years
2

Tumor Recurrence

Time frame
From completion of curative-intent treatment until recurrence or last follow-up, assessed up to approximately 12 years
3

Treatment Response

Time frame
At the end of each treatment line (neoadjuvant, adjuvant or systemic therapy), assessed up to approximately 12 years
4

Incidence of Grade 3-4 Adverse Events

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

Other outcomes

Sponsors and contacts

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