Phase
Condition
Cancer
Breast Cancer
Treatment
N/AClinical Study ID
Ages < 35 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Signed informed consent;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- Patients pathologically diagnosed with hormone receptor positive invasive breastcancer: immunohistochemistry ER positive (≥1%);
- Premenopausal patients with age ≤35 years (at least menstruate once for prior 3months, assess menstruation situation before chemotherapy if have);
- No distant metastasis;
- Clinical stage (TNM) meets at least one of the conditions as follow: T≥2cm or at leastone region of regional lymph node metastasis (including micrometastases);
- Patients must have undergone a surgery and (neo)adjuvant chemotherapy, targetedtherapy, radiotherapy (if necessary) according to Chinese Anti-Cancer Associationguidelines and specifications version 2015 for diagnosis and treatment of breastcancer;
- 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
Exclusion Criteria:
- Pregnant or lactating women or women of childbearing potential reject contraceptivemeasures;
- History of organ transplantation (including autologous bone marrow transplantation andperipheral stem cell transplantation);
- Concurrent malignancies or history of non-breast malignancies within the 5 years priorto study entry, except for curatively treated basal cell and squamous cell carcinomasof the skin, carcinoma in situ of the cervix; peripheral nervous system disorderscaused by diseases or history of obvious mental and central nervous system disorders;
- Prior use of neo-adjuvant chemotherapy after a definite diagnosis;
- Nervous system disorders caused by diseases or obvious mental disorder, which wouldaffect patients right to consent and compliance, or make patients in criticalcondition;
- Serious hepatopathy (e.g., cirrhosis, etc.), nephropathy, respiratory illness,digestive illness or poorly controlled diabetes;
- Cardiac illness with obvious abnormal EKG or clinical symptoms, namely congestiveheart failure, coronary atherosclerotic heart disease with obvious symptoms,arrhythmia difficult to control by drugs, or history of myocardial infarction withinthe 12 months prior to study entry or class III/IV of cardiac function;
- Concurrent treatment in another investigational trial;
- Sensitivity or contraindication to any of the study medications.
Study Design
Connect with a study center
First People's Hospital of FoShan City
FoShan, Guangdong 528000
ChinaSite Not Available
Cancer Hospital Chinese Academy of Medical Sciences
Beijing,
ChinaSite Not Available
Peking University First Hospital
Beijing,
ChinaSite Not Available
Dongguan People's Hospital
Dongguan,
ChinaActive - Recruiting
GuangDong Hospital Of Traditional Chinese Medicine
Guangzhou,
ChinaActive - Recruiting
Guangdong People's Hospital
Guangzhou,
ChinaSite Not Available
Guangdong Provincial Women and Children's Hospital
Guangzhou,
ChinaActive - Recruiting
Guangzhou First Municipal People's Hospital
Guangzhou,
ChinaActive - Recruiting
Guangzhou Women and Childrens Medical Center
Guangzhou,
ChinaActive - Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou,
ChinaActive - Recruiting
Sun Yat-sen University Cancer Center
Guangzhou,
ChinaActive - Recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou,
ChinaActive - Recruiting
Guilin TCMhospital of China
Guilin,
ChinaActive - Recruiting
Zhejiang Provincial People's Hospital
Hangzhou,
ChinaSite Not Available
Harbin Medical University Cancer Hospital
Harbin,
ChinaActive - Recruiting
Yunnan Cancer Hospital
Kunming,
ChinaSite Not Available
Maoming People's Hospital
Maoming,
ChinaActive - Recruiting
The first Affiliated Hospital of Guangxi Medical University
Nanning,
ChinaActive - Recruiting
The Affiliated Hospital of Qingdao University
Qingdao,
ChinaSite Not Available
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou,
ChinaSite Not Available
Affiliated hospital of Guangdong Medicine College
Zhanjiang,
ChinaActive - Recruiting
Lian Jiang People' s Hospital
Zhanjiang,
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou,
ChinaSite Not Available
Zhongshan People's Hospital
Zhongshan,
ChinaActive - Recruiting
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai,
ChinaActive - Recruiting

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