RecruitingPhase 3NCT02535221

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

Randomized Trial of Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With Estrogen Receptor-Positive HER2 Negative Breast Cancer

Sponsor

Peking University

Enrollment

234 participants

Start Date

Jul 29, 2015

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 35 YearsMax Age: 55 Years

Inclusion Criteria7

years old \<age≤55 years old, in premenopausal status(with the judgement by 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 Criteria7

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

Interventions

DRUGGoserelin+TAM+AI

Goserelin 3.6mg subcutaneous injection per 4 weeks, for 16-20weeks. TAM 10mg oral twice a day for the first four weeks(to wait the Goserelin start to work in body) than change to AI 1mg oral once a day with Goserelin for the next 12-16 weeks.

DRUGEpirubicin+CTX+5-Fu

Epirubicin(80-100 mg/m2 Q21 days) + CTX(600 mg/m2 Q 21days) + 5-Fu (600 mg/m2 Q21 days or 200 mg/m2 •day from Day1 to day 21) for four to six cycles.