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

Peking University

Status and phase: Enrolling; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Epirubicin+CTX+5-Fu; Drug: Goserelin+TAM+AI

Study type: Interventional

Funder types: Other

Identifiers

NCT02535221

BCP12

Details and patient eligibility

About

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.

Enrollment: 234 estimated patients

Sex: Female

Ages: 35 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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234 participants in 2 patient groups

Endocrine therapy;

Experimental group

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.

Treatment:

Drug: Goserelin+TAM+AI

Chemotherapy

Active Comparator group

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.

Treatment:

Drug: Epirubicin+CTX+5-Fu