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

NCT02535221 | Recruiting Phase 3

• 1 other identifier: BCP12
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Premenopausal Patients; Estrogen Receptor-Positive HER2 negative

Outcome Measures

Primary Outcomes (1)

• ultrasound response rate

  within 2 weeks before surgery

Secondary Outcomes (1)

• pathological response rate(Miller & Payne standard)

  with 2 weeks after surgery

Study Arms (2)

Endocrine therapy;

EXPERIMENTAL

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

Chemotherapy

ACTIVE COMPARATOR

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

Interventions

Goserelin+TAM+AI DRUG

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.

Also known as: Endocrine therapy

Endocrine therapy;

Epirubicin+CTX+5-Fu DRUG

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.

Also known as: Chemotherapy

Chemotherapy

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Beijing Cancer Hospital Breast Center

Beijing, China

RECRUITING

Related Publications (1)

• Gu C, He Y, Zhang N, Liu Y, Li J, Wang T, Fan T, Fan Z, Ouyang T. A Non-Inferior Randomized Trial of Neoadjuvant Endocrine Therapy Compared to Neoadjuvant Chemotherapy in Premenopausal Patients With Hormone-Responsive and HER2-Negative Lymph Node-Negative Breast Cancer. Cancer Control. 2025 Jan-Dec;32:10732748251339958. doi: 10.1177/10732748251339958. Epub 2025 May 7.

  PMID: 40331570 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Tao Ouyang, MD

  Peking University Cancer Hospital & Institute

  STUDY CHAIR

Central Study Contacts

Tao Ouyang, MD

CONTACT

ouyanghongtao@263.net

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Breast Center of Peking University Cancer Hospital

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: August 28, 2015
• Study Start: July 29, 2015
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 29, 2021

Record last verified: 2021-11

Locations

CN (1)