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

Who is this study for? Patients with Breast Cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 35
Maximum Age: 55
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Cancer Hospital Breast Center
RECRUITING
Beijing
Contact Information
Primary
Tao Ouyang, MD
ouyanghongtao@263.net
Time Frame
Start Date: 2015-07-29
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 234
Treatments
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.
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.
Sponsors
Leads: Peking University

This content was sourced from clinicaltrials.gov

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