Breast cancer
Conditions
Interventions
the first group:TEC with high dose of epirubicin (100mg/m2)
the second group:EC-T with high dose of epirubicin (100mg/m2)
the third group:EC-TC with high dose of epirubicin (100mg/m2)
Sponsors
The first affiliated hospital of AnHui Medical University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Adult Chiniese women aged 18-70 years; 2. The proven pathological diagnosis of Luminal B (Her-2 positive type is excluded) and triple-negative breast cancer by fine-needle or core needle biopsy with measurable tumor lesions ( at least 10 mm by 5 mm thin-slice CT or MRI scanning; at least 20 mm of maximal diameter by CT scannning) or measurable skin lumps ect.The gross lesions with the maximal diameter of at least 10 mm are also included; 3. The confirmed evidence of brease cancer disease without distant metastasis; 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; 5. Adequate organ and bone marrow function defined as follows: Hemoglobin>=100 g/L; Absolute Neutrophil Count (ANC)1.5*10^9/L; Platelets =100*10^9/L; Total serum bilirubin 1.5*Upper Limit of Normal (ULN); Alkaline phosphatase, AST and ALT <=2.5*ULN (without liver metastasis); serum urea <=1.5*ULN; serum creatinine <=1.5*ULN; 6. Normal cardiac funtion with at least 50% of left ventricular ejection fraction (LVEF); 7. No history of chemotherapy, radiotherapy and hormonal therapy; 8. The proven pathological evidence of occult breast cancer with anxillary lymph nodes as measurable lesions; 9. Willingness to comply with treatment plans such as chemotherapy and surgery; evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspect of the study; 10.Medically confirmed post-menopausal status and surgical sterilization or agreement to medically legal contraceptive control within the trial and 3 months following the trial; negative serum or urine pregnancy test without feeding status.
Exclusion criteria
Exclusion criteria: 1. Clinical stage IIA and IIB breast cancer without the willingness to keep breasts; 2. Pathological Her-2 positive and Luminal A patients confirmed by biopsy; 3. Known active uncontrolled cardiovascular disease, blood coagulation disorders, connective tissue disease and severe inflammatory disease ect.; 4. History of chemotherapy, radiotherapy and hormonal therapy; 5. Concurrent with other tumor disease except cured skin basal cell carcinoma and cervical carcinoma in situ; 6. LVEF less than 50%; 7. Patients in feeding or pregnant status; 8. Mental disorders or patients unable to comply with the trial plans.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective reaction rate;Disease free survival;operative resection rate;overall survival; | — |
Countries
China
Contacts
Public ContactPan yueyin
Outcome results
None listed