Breast Cancer
Conditions
Keywords
Triple negative breast cancer, adjuvant chemotherapy
Brief summary
This study is designed to investigate the efficacy of carboplatin, as a post-operative adjuvant chemotherapy for triple negative breast cancer patients who have pathologic residual cancer after the preoperative chemotherapy.
Detailed description
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.
Interventions
DRUGcarboplatin
carboplatin as adjuvant chemotherapy
Sponsors
Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival (DFS) | up to 3 years | To compare DFS between carboplatin and observation within non-pCR (complete remission) patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | up to 5years | To compare overall survival (OS) between carboplatin and observation within non-pCR patients. |
| pCR rate | up to 3 years | To assess the pCR rate (no residual invasive carcinoma in primary breast and axillary lymph node) within total TNBC patients. |
| The percentage of patients who receive breast conserving surgery. | up to 3years | To assess the percentage of patients who receive breast conserving surgery within total triple negative breast cancer patients |
| Number of adverse events | up to 3years | Number of adverse events in patients with non-pCR. |
Other
| Measure | Time frame |
|---|---|
| difference in gene expression pattern | up to 5 years |
Contacts
Primary ContactByeong Woo Park, MD, PhD
Outcome results
None listed