In Neo-adjuvant period Four cycles of 60 mg/m2 doxorubicin and 600 mg/m2 cyclophosphamide therapy at 3-week intervals followed by four cycles of 100 mg/m2 docetaxel at 3-week intervals.
In POST Neo-adjuvant period
Randomization:
At the time of post neo-adjuvant period, the patients will be assigned to each treatment group in a 1:1 ratio i.e. carboplatin AUC 6 group vs. observation group. Six cycles of carboplatin (AUC=6) on the first day of every 21 days.
Age
20–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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)
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
You may not be if
1. Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
2. Patients who underwent surgery for breast cancer
3. Patients with a history of uncompensated congestive heart failure
4. Patients with inflammatory breast cancer (T4d)
5. Patients without primary tumor (T0)
6. Patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer
7. Known hypersensitivity to any of the study drugs
Clareo Health | A Phase III Trial of Carboplatin as Adjuvant Chemotherapy in Triple Negative Breast Cancer
