Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is an exploratory interventional study that initiates chemotherapy with letrozole in patients with estrogen receptor positive/HER2-negative breast cancer preoperably.

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

Details

• Lead Sponsor: National Cancer Center, Korea
• Treatments: Cyclophosphamide; Docetaxel; Doxorubicin; Estrogens; Letrozole; Leuprolide; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Pathologically proven breast cancer patients who are candidate of neoadjuvant chemotherapy with AC followed by Docetaxel

• Age: 19-70 years

• ER or PR positive ,cT2-3N0 or cT1-3/N+ M0 (ER-positive ≥1% nuclear staining by immunohistochemistry , Allred score≥3 )

• Available FFPE tissue for biomarker study

• HER2-negative by ASCO/CAP guideline

• Patients who agree to adequate contraception

• ECOG scores of 0-2

• Normal or acceptable kidney, liver, cardiovascular, and bone marrow functions

• Patients who provide consent

Exclusion Criteria:

• Inflammatory breast cancer

• Distant metastasis

• Cerebral vascular accidents including transient ischemic attack

• Pulmanary thromboembolism or deep vein thrombosis with 6 months; however, patients who received more than 6 weeks of anticoagulation within 6 months and remains asymptomatic are eligible.

• With a history of malignant tumor or complicated with other malignant tumors in addition to breast cancer, except for non-melanoma skin cancer, curatively resected early gastric cancer, differentiated thyoid cancer < 1 cm, or other cured malignant tumor without recurrence for at least 3 years

• Ejection Fraction <55% by MUGA scan / Echo CG

• No available tissue for biomarker study

• Pregnant or lactating women

• Patients with other serious diseases or medical conditions: Pituitary adenoma, Malabsorption syndrome, Major resection of gastrointestinal tract, Corrected QT interval > 480 msec, Congestive heart failure or unstable angina pectoris, myocardial infarction, stent insertion, angioplasty, coronary bypass surgery, symptomatic peripheral artery disease within 6 months before the enrollment

• NYHA class III or IV congestive heart failure

• Uncontrolled hypertension and uncontrolled high-risk arrhythmia considered by the investigator

• Major surgery, major trauma, and/or unhealed wound, fracture, or ulcer within 4 weeks

• Acute hemorrhage or hemorrhagic tendency

• Obvious neurological or psychiatric disorders, including psychosis, epileptic dementia and other diseases which may affect the understanding and sign of the informed consent

• Uncontrolled acute infection

• Patients with allergic constitution and any known or suspected drug allergy

• Concurrent use of other investigational drugs; or participating in other clinical trials involving investigational drugs within 30 days before this study

• Patients with mental illness or other conditions affecting the patient compliance

• Not suitable for the trial considered by the investigator