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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Goserelin+TAM+AI; Drug: Epirubicin+CTX+5-Fu

• Study Type: Interventional
• Enrollment (Anticipated): 234
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Tao Ouyang, MD; Email: ouyanghongtao@263.net

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Cancer Hospital Breast Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endocrine therapy; 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.	Drug: 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.; Other Names: Endocrine therapy
Active Comparator: Chemotherapy; 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.	Drug: 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.; Other Names: Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ultrasound response rate	within 2 weeks before surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
pathological response rate(Miller & Payne standard)	with 2 weeks after surgery

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Study Chair: Tao Ouyang, MD, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2015
• Primary Completion (Anticipated): June 30, 2026
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: June 9, 2015
• First Submitted That Met QC Criteria: August 26, 2015
• First Posted (Estimate): August 28, 2015

Study Record Updates

• Last Update Posted (Actual): November 29, 2021
• Last Update Submitted That Met QC Criteria: November 26, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Premenopausal Patients; Estrogen Receptor-Positive HER2 negative
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Epirubicin; Goserelin
• Other Study ID Numbers: BCP12