Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer
Recruiting · NCT02535221 · Interventional (participants receive a specific treatment) · Lead sponsor: Peking University
View the official record on ClinicalTrials.gov →Interventions studied
Epirubicin+CTX+5-FuGoserelin+TAM+AI
What this trial is 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.
Who can take part
Age range
35 Years to 55 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Beijing Cancer Hospital Breast Center - Beijing, China