PersonaLized neoAdjuvant Strategy ER Positive and HER2 Negative Breast Cancer TO Increase BCS Rate

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Letrozole; Leuprolide

Criteria

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