A Phase III Trial of Carboplatin as Adjuvant Chemotherapy in Triple Negative Breast Cancer

Inclusion Criteria

• •Clinical diagnosis of breast cancer
• •1. Female patients
• •2. Histologically confirmed invasive breast cancer
• •1. Primary tumor greater than 2cm diameter, measured by mammography and sonography
• •2. Any N
• •3. ER (estrogen receptor)/ PR (progesterone receptor) / HER2 (negative/ negative/ negative)(ER \<1%, PR\<1%, IHC 0, 1+ or FISH - in case of IHC (immuno-histochemistry) 2+)
• •4. No evidence of metastasis (M0)
• •5. No prior hormonal, chemotherapy or radiotherapy is allowed.
• •6. No breast operation other than biopsy to make diagnosis is allowed.
• •7. Age: 20-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)
• •8. Adequate hematopoietic function: Absolute granulocyte count 1500/mm3, platelet 100,000/mm3, Hemoglobin 10 g/mm3
• •9. Adequate renal function: Serum creatinine 1.5 mg/dl
• •10. Adequate hepatic function: total bilirubin: 1.5 mg/dl, AST(aspartate aminotransferase)/ALT (alanine transaminase): 2 times normal, Alkaline phosphatase:2 times normal
• •11. Written informed consent
• •12. Normal mental function to understand and sign the consent
• •13. Cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment.
• •14. LVEF (left ventricular ejection fraction)50% by MUGA (multiple gated acquisition scan) or Echocardiogram taken within 1 mo of enrollment