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

November 26, 2021 updated by: Tao OUYANG, Peking University

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

234

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: within 2 weeks before surgery
within 2 weeks before surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCP12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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