Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||N/A - 35 Years|
Inclusion Criteria:1. Signed informed consent; 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; 3. Patients pathologically diagnosed with hormone receptor positive invasive breast cancer: immunohistochemistry ER positive (≥1%); 4. Premenopausal patients with age ≤35 years (at least menstruate once for prior 3 months, assess menstruation situation before chemotherapy if have); 5. No distant metastasis; 6. Clinical stage (TNM) meets at least one of the conditions as follow: T≥2cm or at least one region of regional lymph node metastasis (including micrometastases); 7. Patients must have undergone a surgery and (neo)adjuvant chemotherapy, targeted therapy, radiotherapy (if necessary) according to Chinese Anti-Cancer Association guidelines and specifications version 2015 for diagnosis and treatment of breast cancer; 8. Indexes of hematology and biochemistry conform to following standards: HGB≥10g/dl, WBC≥4,000/mm3, PLT≥100,000/mm3, GOT, GPT, ALP≤2xULN, TBIL, DBIL, CCr≤1.5xULN.
Exclusion Criteria:1. Pregnant or lactating women or women of childbearing potential reject contraceptive measures; 2. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation); 3. Concurrent malignancies or history of non-breast malignancies within the 5 years prior to study entry, except for curatively treated basal cell and squamous cell carcinomas of the skin, carcinoma in situ of the cervix; peripheral nervous system disorders caused by diseases or history of obvious mental and central nervous system disorders; 4. Prior use of neo-adjuvant chemotherapy after a definite diagnosis; 5. Nervous system disorders caused by diseases or obvious mental disorder, which would affect patients right to consent and compliance, or make patients in critical condition; 6. Serious hepatopathy (e.g., cirrhosis, etc.), nephropathy, respiratory illness, digestive illness or poorly controlled diabetes; 7. Cardiac illness with obvious abnormal EKG or clinical symptoms, namely congestive heart failure, coronary atherosclerotic heart disease with obvious symptoms, arrhythmia difficult to control by drugs, or history of myocardial infarction within the 12 months prior to study entry or class III/IV of cardiac function; 8. Concurrent treatment in another investigational trial; 9. Sensitivity or contraindication to any of the study medications.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|First Affiliated Hospital, Sun Yat-Sen University|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: Goserelin and aromatase inhibitors
Goserelin: GnRH analogues goserelin 3.6 mg administered intravenously every 28 days, for 5 years. AI: no restriction of specific drugs, oral by standard dose of post-menopause breast cancer, for 5 years.
Active Comparator: Goserelin and tamoxifen
Goserelin: GnRH analogues goserelin 3.6 mg administered intravenously every 28 days, for 5 years. Tamoxifen: 20mg oral for every day, for 5 years.
Drug: - Goserelin
Drug: - Tamoxifen
Drug: - Aromatase Inhibitors
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.