breast cancer
Conditions
Interventions
Experimental group1:3-year GnRHa+ AI ? 2-year GnRHa+ TAM
Experimental group2:3-year GnRHa+ AI ? 2-year TAM
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form, understand the study and be willing to follow all experimental procedures; 2. Premenopausal women, aged 18 to 40 years; 3. Histologically confirmed invasive breast cancer patients; 4. Hormone receptor positive, that is, immunohistochemical ER or PR>=10%+; 5. After pre-treatment puncture or standard surgery, pathologically confirmed combined risk factors (one or more of the following): (1) Histological grade G2 or G3; (2) Pathologically confirmed T2 and above; (3) Lymph node positive; (4) When T20%+ should be satisfied at the same time. 6. Eastern Cooperative Oncology Group (ECOG) score 0-1; 7. Appropriate organ and hematopoietic function, no serious organ dysfunction and immune deficiency in laboratory examination; 8. Consent to abstinence or use of effective contraception during treatment and for at least 7 months after the last dose of study treatment.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breastfeeding, of childbearing age and have a positive baseline pregnancy test; 2. Have any definite history of drug allergy, or have severe allergic reactions to any of the components of the test drug (NCI-CTCAE 5.0 grade greater than 3); 3. Patients with bilateral breast cancer, inflammatory breast cancer, and tumor stage T4; 4. Patients with initial tumor stage IV (metastatic) breast cancer; 5. History of congestive heart failure, unstable angina, arrhythmia or myocardial infarction; 6. Other invasive tumors (including second primary breast cancer), but subjects who have been cured and have survived disease-free for at least 5 years can be enrolled; 7. Breast cancer patients who have previously received chemotherapy, endocrine therapy or anti-HER2 biological therapy or breast surgery (except for diagnostic biopsy of primary breast cancer); 8. Known active bacterial, viral, fungal, mycobacterial, parasitic or other infection (excluding nail bed dermatophyte infection) or any major systemic infection event requiring intravenous antibiotic treatment or hospitalization within 4 weeks prior to enrollment ; 9. Those who are positive for either human immunodeficiency virus antibody or Treponema pallidum antibody need to be excluded; 10. Both HBV surface antigen and HBV core antibody are positive. If any of the above is positive, the peripheral blood hepatitis B virus DNA titer test is required to be < 1x10^3 IU/ml before entering the group; 11. Suffering from sudden lung disease, interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease, etc., except for local interstitial pneumonia induced by radiotherapy; 12. A history of drug abuse, or alcoholism or drug addicts; 13. Those with a clear history of neurological or mental disorders, such as epilepsy, dementia, and poor compliance; 14. According to the judgment of the investigator, any subject who has a reduced possibility of enrolling (such as frailty, etc.), has a tendency to non-compliance during the study period, or has other pathologies that complicate enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease free survival ; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;distant disease-free survival ; | — |
Countries
China
Contacts
Public ContactTang Jun
Sun Yat-sen University Cancer Center
Outcome results
None listed