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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02535221
• Other study ID #: BCP12
• Status: Recruiting
• Phase: Phase 3
• Start date: July 29, 2015
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2021
• Source: Peking University
• Contact: Tao Ouyang, MD
• Email: ouyanghongtao[@]263.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital Breast Center	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ultrasound response rate		within 2 weeks before surgery
Secondary	pathological response rate(Miller & Payne standard)		with 2 weeks after surgery