Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study proposes to prove that the efficacy of adjuvant endocrine therapy for the premenopausal HR positive breast cancer patients is non-inferiority to adjuvant chemotherapy assessed by ultrasound response rate.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University
• Treatments: Epirubicin; Estrogens; Goserelin

Criteria

Inclusion Criteria:

• 35 years oldresearchers when the patients are recruited) Histologically confirmed primary invasive breast cancer

• Stage: T2N0M0(cT>2cm, SLNB negative), hard to proceed the breast conserving surgery(not feasible or may affect the appearance of breast)

• Histologically confirmed HR+ (ER or PR positive, and >50% cell in IHC) HER2 negative breast cancer by pathological evaluation

• No other previous treatment for primary breast cancer

• Without other tumor or unstable complication or uncontrolled infection

• No contradiction for the third generation AIs, LHRHa, chemotherapy

• Attend the study voluntarily, sign the informed consent.

Exclusion Criteria:

• Metastasis disease by pathological or radiological diagnosis

• the history of other tumor

• contradiction for the third generation AIs, LHRHa, chemotherapy

• Contradiction for adjuvant chemotherapy: serious cardiology or cerebral vessel disease, liver or kidney disfunction, blood system disease, the other situation or complication that are not suitable or cannot adaptable for chemotherapy

• Contradiction for proceeding surgery: contradiction for anesthesia, large lesion,T4, lymph node positive

• other situation not suitable for the research: psychological disease, mental disorder, social problem, geographic problem

• have been attendance in other anti-tumor treatment or other clinical trials 8) reject to attend the study