Breast Cancer
Conditions
Interventions
Case series:NA
Sponsors
The Second Affiliated Hospital of Dalian Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Female, aged between 18 and 60 years at screening, and meeting the following criteria for premenopausal status: (1) Menstrual periods within the past year; (2) Estradiol levels >= 10 pg/mL and follicle-stimulating hormone (FSH) 12 months. 5. ECOG performance status <= 1. 6. Willingness to sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have undergone bilateral oophorectomy, ovarian radiation therapy, hypophysectomy, adrenalectomy, or have pituitary lesions. 2. Patients who have undergone major surgery other than breast cancer surgery within 4 weeks prior to randomization. 3. Patients diagnosed with other cancers within the past 5 years, except for surgically resected basal cell or squamous cell carcinoma of the skin, or surgically resected carcinoma in situ of the cervix. 4. Patients with infectious diseases requiring intramuscular or intravenous drug therapy at the time of screening. 5. Patients with severe diseases, including but not limited to: acute coronary syndrome, history of coronary revascularization within 6 months prior to screening, New York Heart Association (NYHA) class = II heart failure, severe unstable ventricular arrhythmias; or with conditions such as fundus disease, severe osteoporosis, uncontrolled seizures, extensive bilateral lung disease diagnosed by high-resolution computed tomography (HRCT), mental illness impeding the signing of informed consent, etc. 6. Patients with a history of bleeding tendencies (e.g., disseminated intravascular coagulation [DIC] or coagulation factor deficiency) or a history of long-term anticoagulant therapy (excluding antiplatelet therapy). 7. Patients with a history of deep vein thrombosis, pulmonary embolism, or stroke. 8. Patients with a known allergic reaction to gonadotropin-releasing hormone (GnRH) agonists, tamoxifen, or any of their excipients. 9. Patients unwilling or unable to discontinue medications affecting sex hormone levels. 10. Pregnant or breastfeeding women. 11. Any other conditions deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain score; | — |
Secondary
| Measure | Time frame |
|---|---|
| quality of life; | — |
Countries
China
Contacts
Public ContactMan Li
The Second Affiliated Hospital of Dalian Medical University
Outcome results
None listed