Breast cancer
Conditions
Interventions
Intervention group:GnRHa
Sponsors
The Third Bethune Hospital of Jilin University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged between 18 and 45 years at screening, who meet the following criteria for premenopausal status: (1) Had menstrual periods within 1 year prior to enrollment; (2) And serum estradiol (E2) > 30 pg/mL and follicle-stimulating hormone (FSH) 0.5 ng/mL. 2. Histologically confirmed primary ER-negative breast cancer by immunohistochemistry (IHC); Tumor staged as T1 to T3 with node-positive, M0 disease, according to the 8th edition of the AJCC Cancer Staging Manual. 3. Patients who have undergone breast cancer-related surgery and are assessed by the investigator as candidates for adjuvant chemotherapy. 4. Eastern Cooperative Oncology Group (ECOG) performance status score of <=1. 5. Women of childbearing potential with a negative pregnancy test and their partners must agree to use effective non-hormonal contraception throughout the treatment period and for at least 3 months after the last dose of study drug. 6. Patients who have voluntarily signed written informed consent prior to the screening visit, after full explanation of the nature and scope of the study, and who are willing and able to comply with the study protocol and complete all required procedures.
Exclusion criteria
Exclusion criteria: 1. Evidence of distant metastatic lesions. 2. Prior neoadjuvant or adjuvant endocrine therapy for breast cancer. 3. History of bilateral oophorectomy, ovarian radiation, hypophysectomy, adrenalectomy, or diagnosed pituitary disorders. 4. Diagnosis of other malignancies within the past 5 years, except for surgically resected basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. 5. Presence of severe comorbidities, including but not limited to: acute coronary syndrome within 6 months prior to screening, history of coronary revascularization, NYHA Class II or higher heart failure, severe unstable ventricular arrhythmias; or presence at screening of fundus disease, severe osteoporosis, uncontrolled epilepsy, extensive bilateral pulmonary disease confirmed by high-resolution CT, psychiatric disorders affecting informed consent, etc. 6. History of bleeding tendency (e.g., disseminated intravascular coagulation [DIC] or coagulation factor deficiency) or long-term anticoagulant therapy (excluding antiplatelet therapy). 7. Laboratory abnormalities at screening: total bilirubin >1.5×ULN, ALT or AST >2.5×ULN, platelet count 460 ms, or creatinine clearance = 20,000 IU/mL (approx. 105 copies/mL) – HBeAg-negative: HBV DNA >= 2,000 IU/mL (approx. 104 copies/mL) (2) ALT >= 2×ULN 9. Positive for any of the following: hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TPAb). 10. Patients unwilling or unable to discontinue medications known to affect sex hormone levels. 11. Participation in any clinical study involving investigational drugs, biologics, or devices within 1 month prior to screening or within five half-lives of the investigational product, whichever is longer. 12. Pregnant or breastfeeding women. 13. Any other conditions deemed inappropriate for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| anti-Müllerian hormone, AMH; | — |
Secondary
| Measure | Time frame |
|---|---|
| anti-Müllerian hormone, AMH;Follicle-Stimulating Hormone, FSH;Estradiol, E2;Antral Follicle Count;Luteinizing Hormone,LH; | — |
Countries
China
Contacts
Public ContactWan Wang
The Third Bethune Hospital of Jilin University
Outcome results
None listed