Overview

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 old researchers 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