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

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Goserelin+TAM+AI

Epirubicin+CTX+5-Fu

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Premenopausal Patients, Estrogen Receptor-Positive HER2 negative

Eligibility Criteria

35 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Beijing Cancer Hospital Breast CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endocrine therapy;

Chemotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

ultrasound response rate

Secondary Outcome Measures

pathological response rate(Miller & Payne standard)

Full Information

NCT ID

NCT02535221

First Posted

June 9, 2015

Last Updated

November 26, 2021

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT02535221

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

July 29, 2015 (Actual)

Primary Completion Date

June 30, 2026 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Premenopausal Patients, Estrogen Receptor-Positive HER2 negative

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

234 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Endocrine therapy;

Arm Type

Experimental

Arm Description

Arm Title

Chemotherapy

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Goserelin+TAM+AI

Other Intervention Name(s)

Endocrine therapy

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Epirubicin+CTX+5-Fu

Other Intervention Name(s)

Chemotherapy

Intervention Description

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 Measure Information:

Title

ultrasound response rate

Time Frame

within 2 weeks before surgery

Secondary Outcome Measure Information:

Title

pathological response rate(Miller & Payne standard)

Time Frame

with 2 weeks after surgery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tao Ouyang, MD

ouyanghongtao@263.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tao Ouyang, MD

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Study Chair

Facility Information:

Facility Name

Beijing Cancer Hospital Breast Center

City

Beijing

Country

China

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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