Clinical trial · Interventional
Neoadjuvant Tamoxifen in Locally Advanced Breast Cancer in a Low/Middle Income Country
Neoadjuvant Endocrine Therapy in Locally Advanced Hormone Receptor Positive Breast Cancer in a Low-Resource, Middle-Income Setting (Guatemala)
NCT02806544CI-TRIAL-00025691completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the feasibility and efficacy of neoadjuvant tamoxifen for patients with locally advanced hormone receptor positive breast cancer in a low/middle income country.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tamoxifen
- description
- Tamoxifen 20mg by mouth daily
- interventionNames
- Drug: Tamoxifen
Primary outcomes (1)
- measure
- Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility
- timeFrame
- 4-6 months
- description
- Feasibility is defined as the ability to recruit the stated number of patients and fifty percent of participants completing the trial. Completing the trial is defined as reaching surgery if they are a responder to tamoxifen or obtaining the six week biopsy specimen if they are a non-responder.
Secondary outcomes (5)
- measure
- Number of Participants With Definitive Surgery in Responders to Neoadjuvant Tamoxifen
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient evaluated and treated at INCAN * Patients must provide informed consent * Patient must be ≥ 18 years of age. * Life expectancy ≥ 6 months * Clinical locally advance breast cancer (Stage IIB or III) * Pathologically confirmed diagnosis of estrogen receptor (ER)-positive or progesterone receptor (PR)-positive breast cancer with ER or PR Allred Score \> 4 * Patient must have an ECOG Performance Status of 0-2 * Patients must be able to swallow and retain oral medication Exclusion Criteria: * Patient must not have received any prior chemotherapy, radiation therapy, or biologic therapy for invasive breast cancer within the past five years * Patient must not be pregnant or nursing * Patient must not have had any prior malignancy except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years. * Women of childbearing age unable or unwilling to use contraception
References
Publications (0)
Data not yet available
No reference posted for this study.