Clinical trial · Interventional
PersonaLized neoAdjuvant Strategy ER Positive and HER2 Negative Breast Cancer TO Increase BCS Rate
Multi-institutional Study to Increase Breast Conserving Surgery (BCS) Rate With Personalized Neoadjuvant Strategy in ER Positive and HER2 Negative Breast Cancer Patients for Whom BCS is Not Feasible
NCT03900637CI-TRIAL-00079274active not recruitingPhase 2ClinicalTrials.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)
In ER+ and HER2- breast cancer(BC) patients for whom BCS is not feasible, we investigate the rate of BCS can be increased while decreasing unnecessary chemotherapy thru selective neoadjuvant chemotherapy or neoadjuvant endocrine therapy using tools of nodal status, Ki-67, and multigene assay(Mammaprint)
Conditions
Conditions (1)
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 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Letrozole | Drug | Letrozole | ALIAS |
| Leuprorelin acetate | Drug | Leuprolide | ALIAS |
| MammaPrint | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 1. MammaPrint high risk : * Neoadjuvant chemotherapy : Adriamycin/Cyclophosphamide #4 followed by Docetaxel #4 2. MammaPrint low risk : * Premenopausal women : Letrozole 2.5mg PO QD + leuprorelin acetate 3.6mg SQ every 4weeks during 16 weeks (if needed, maximum for 24 weeks) * Postmenopausal women : Letrozole 2.5mg PO QD during 16 weeks (if needed, maximum for 24 weeks)
- interventionNames
- Drug: Leuprorelin acetate
- Drug: Letrozole
- Genetic: MammaPrint
Primary outcomes (1)
- measure
- Conversion Rate
- timeFrame
- 4 months(maximum 6 months)
- description
- Evaluate the conversion rate from BCS-ineligible to BCS-eligible patients
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histopathologically and immunohistochemically confirmed ER+ and HER2- BC patients 2. Stage I-IIIA BC patients with detectable tumor sizes 3. BC patients for whom BCS is not feasible due to tumor sizes or locations (two surgeons at each institution evaluate the infeasibility of BCS) 4. Patients without distant metastasis which were identified pathologically or radiologically 5. Female patients ≥ 19 years * Diagnosis of menopause is defined as no menstruation for 1-year or both ovaries removed surgically 6. ECOG 0-2 7. Patients with adequate bone marrow function * Hemoglobin 10 g/dL, ANC 1,500/mm3, Plt 100,000/mm3 8. Patients with adequate kidney function * serum Cr ≤ 1.5 mg/dL 9. Patients with adequate liver function * Bilirubin: ≤ 1.5 times of upper normal limit * AST/ALT: ≤ 1.5 times of upper normal limit * Alkaline phosphatase: ≤ 1.5 times of upper normal limit 10. Patients who decided to voluntarily participate in this trial with written informed consent Exclusion Criteria: 1. History of treatment for ipsilateral BC or breast carcinoma in situ 2. Confirmed distant metastasis of BC 3. History of cancer other than BC 4. Pregnant (positive pregnancy test within a week of enrollment) or breast-feeding patients 5. Uncontrolled severe infection 6. Psychiatric illness or epilepsy 7. Male BC patients 8. Inability to understand and willingness to sign a written informed consent 9. Mammographic extensive microcalcification 10. Multicentral, Bilateral BC 11. History of chemotherapy or endocrine therapy on contralateral BC for the past 2 years 12. ER- 13. HER2+ 14. Undetectable and unmeasurable primary tumor size
References
Publications (0)
Data not yet available
No reference posted for this study.