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

Phase 3

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Goserelin+TAM+AI; Drug: Epirubicin+CTX+5-Fu

• Registration Number: NCT02535221
• Lead Sponsor: Peking University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-09
• Study Start: 2015-07-29
• Study First Submitted QC: 2015-08-26
• Study First Posted: 2015-08-28
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-26
• Last Update Posted: 2021-11-29
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 234

Inclusion Criteria

• 35 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endocrine therapy;	Goserelin+TAM+AI	Interventions：Goserelin+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.
Chemotherapy	Epirubicin+CTX+5-Fu	Interventions：Epirubicin+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.

Primary Outcome Measures

Name	Time	Method
ultrasound response rate	within 2 weeks before surgery

Secondary Outcome Measures

Name	Time	Method
pathological response rate(Miller & Payne standard)	with 2 weeks after surgery

Trial Locations

Locations (1)

Beijing Cancer Hospital Breast Center; 🇨🇳 Beijing, China