Breast Cancer
Conditions
Interventions
Experimental Group:Intramuscular injection of goserelin microspheres was administered for the first time 2 weeks before the start of chemotherapy (D-14 to D-1) and continued throughout the chemotherap
Sponsors
China-Japan Union Hospital of Jilin University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Female, aged 18 37 pmol/L, follicle-stimulating hormone (FSH) 0.5 ng/mL (note: corrected from "mg/mL" to "ng/mL" as AMH is typically measured in ng/mL in clinical practice) within 4 weeks before enrollment; 2. Histologically confirmed primary breast cancer by immunohistochemistry (IHC), with TNM stage T1-3, N0-3, M0 according to the 8th Edition AJCC Cancer Staging Manual; 3.Having undergone breast cancer-related surgery, and adjuvant chemotherapy is planned as judged by the investigator; 4.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 5.Fertile female patients with a negative pregnancy test and their partners must agree to use effective non-hormonal contraceptive measures for contraception during the entire study treatment period and for at least 3 months after the last dose of the study drug; 6.After being informed of the scope and nature of the study, voluntarily signing a written informed consent form before the screening visit, agreeing to comply with the study restrictions, and being able to cooperate in completing all required examinations.
Exclusion criteria
Exclusion criteria: 1. There is evidence indicating the presence of distant metastatic lesions; 2. Those who have previously received neoadjuvant chemotherapy/endocrine therapy for breast cancer; 3. Those who have undergone bilateral oophorectomy, ovarian radiotherapy, pituitary resection, adrenal resection, or have pituitary lesions; Other cancer diseases diagnosed within 4 to 5 years, except for surgically removed basal or squamous cell carcinoma of the skin; 5. Suffering from serious diseases, including but not limited to: having acute coronary syndrome, a history of coronary revascularization within 6 months prior to screening, New York Heart Association (NYHA) grade =II heart failure, and severe unstable ventricular arrhythmia; Or there may be retinal diseases, severe osteoporosis, uncontrollable epileptic seizures, extensive bilateral lung diseases confirmed by high-resolution computed tomography, mental disorders that hinder the signing of informed consent, etc. during the screening process; 6. Those with a history of bleeding tendency (i.e., disseminated intravascular coagulation [DIC] or deficiency of coagulation factors) or a long-term history of anticoagulant treatment (excluding antiplatelet aggregation therapy); 7. During screening, total bilirubin >1.5 times the upper limit of normal (ULN), glutamate-alanine aminotransferase and glutamate-aspartate aminotransferase (ALT and AST) >2.5×ULN, platelet count 460 ms, creatinine clearance rate = 20,000 IU/mL (equivalent to 105 copies /mL); Hbeag-negative patients, HBV DNA>=2000 IU/mL (equivalent to 104 copies /mL); 2. ALT >=2×ULN 9. Those who test positive for any one of the following antibodies: anti-hepatitis C virus (HCV-Ab) antibody, anti-human immunodeficiency virus (HIV) antibody, or anti-Treponema pallidum antibody (TPAb); 10. Patients who are unwilling to discontinue or are not suitable to discontinue drugs that affect sex hormone levels; 11. Those who have participated in any clinical research on research drugs, research biological products or research medical devices and have been out of use for less than one month before screening or within five half-lives of the corresponding drugs (whichever is longer); 12. Pregnant and lactating women; 13. Other circumstances that the researchers consider unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AMH recovery rate (with AMH > 0.5 ng/mL) at 12 months after chemotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| AMH recovery rate (with AMH > 0.5 ng/mL) at 6 months after chemotherapy;Antral follicle count (AFC) under B-ultrasound;Estradiol,E2;Follicle-Stimulating Hormone,FSH;Luteinizing Hormone,LH; | — |
Countries
China
Contacts
Public ContactWan Wang
Department of Breast Surgery, China-Japan Union Hospital of Jilin University
Outcome results
None listed