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

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Apr 2, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring a new approach to treat women with a specific type of breast cancer known as ER positive and HER2 negative. The goal is to see if we can safely increase the number of patients who can have breast-conserving surgery (BCS), which is a procedure that removes the tumor but leaves the rest of the breast intact. The trial will test different treatments, including chemotherapy and hormone therapy, to find out which is most effective while minimizing unnecessary treatment. Researchers will use specific tests to help determine the best treatment options for each patient.

To be eligible for this trial, participants need to be women aged 19 and older with confirmed ER positive and HER2 negative breast cancer that is in stages I to IIIA. They should have tumors that are too large or in a location that makes BCS difficult. Key health requirements include having good blood and organ function, and patients must not have any distant spread of cancer. Those who join the trial can expect close monitoring and support throughout their treatment journey, and their participation will help advance understanding of how to improve breast cancer care for others.

Gender

FEMALE

Eligibility 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