breast cancer
Conditions
Interventions
study group:pirarubicin plus cyclophosphamide
control group:epirubicin plus cyclophosphamide
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Early breast cancer (radical or conserving operation) adjuvant chemotherapy: 1. Diagnosed as female invasive breast cancer patients by pathology after receiving modified radical mastectomy or breast conserving operation (the patients must accept the radiotherapy after breast conserving operation); 2. Each center must receive 4 cycles of TC or EC chemotherapy formulated by primary sponsor (must be in accordance with the dose and mode of administration of this study); 3. Patients must be able to provide all of the following clinical characteristics: pathological type and grade, tumor stage, the existence of cancer embolus, the existence of neural invasion, axillary lymph node dissection or sentinel lymph node number, number of axillary lymph node metastasis, ER, PR, HER2 (for HER2++ patients, FISH detection must be done), Ki-67; 4. Age: 18-65 years old; 5. KPS score more thab 70; 6. The function of liver and kidney, hematopoietic function of bone marrow and other important organs function are normal; (1) HB more than 9.0 g/dl, ANC more than 1.5*10^3/mm^3, PLT more than 10*10^4/mm^3, WBC more than 4*10^3/mm^3 (2) The serum creatinine, bilirubin, GOT and GPT is no more than UNL. 7. Normal cardiac function: no organic heart disease, arrhythmia history and normal left ventricular ejection fraction (55-80%); 8. Serum or urine pregnancy test was negative before childbearing age female enter the study and the medical acceptable method for contraception is used for premenopausal female during the study period; 9. The subjects have signed a written informed consent before the study begins.
Exclusion criteria
Exclusion criteria: 1. Previously chemotherapy received; 2. The existence of dysfunction of the cardiac and other important organs. Active or clinically significant heart disease including: The congestive heart failure: the New York Heart Association (NYHA) higher than II level; The activity of the coronary artery lesions; The arrhythmia need other drug therapy beside of beta blockers or digoxin; The unstable angina pectoris (rest angina pectoris), the new emergence of angina (within 3 months) or myocardial nfarction (within 6 months)before randomized. 3. Mediastinal irradiation received; 4. Subjects whose HER2 +++ and/or HER2 FISH detecting with the presence of HER2 gene over expression intend to receive trastuzumab treatment; 5. Subjects who can not provide related clinical pathological characteristics; 6. Subjects who can not be compliance or are unwilling or unable to accept their follow-up evaluation; 7. Any situation when subjects did not meet in the study by the judgement of investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ECG;echocardiogram;serum troponin I; | — |
Secondary
| Measure | Time frame |
|---|---|
| cardiac events-free survival;hematologic toxicity;alopecia;gastrointestinal reaction; | — |
Countries
China
Contacts
Public ContactXU BINGHE
Outcome results
None listed