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| ID | Type | Description | Link |
|---|---|---|---|
| DA-TNBC | Other Grant/Funding Number | DA-TNBC |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carboplatin chemotherapy | Experimental | 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. |
|
| Observation arm | No Intervention | In this observation arm, patients should be follow up with regular interval without treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | carboplatin as adjuvant chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | To compare DFS between carboplatin and observation within non-pCR (complete remission) patients | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | To compare overall survival (OS) between carboplatin and observation within non-pCR patients. | up to 5years |
| pCR rate | To assess the pCR rate (no residual invasive carcinoma in primary breast and axillary lymph node) within total TNBC patients. |
| Measure | Description | Time Frame |
|---|---|---|
| difference in gene expression pattern | up to 5 years |
Inclusion Criteria:
Clinical diagnosis of breast cancer
Female patients
Histologically confirmed invasive breast cancer
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+)
No evidence of metastasis (M0)
No prior hormonal, chemotherapy or radiotherapy is allowed.
No breast operation other than biopsy to make diagnosis is allowed.
Age: 20-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)
Adequate hematopoietic function: Absolute granulocyte count 1500/mm3, platelet 100,000/mm3, Hemoglobin 10 g/mm3
Adequate renal function: Serum creatinine 1.5 mg/dl
Adequate hepatic function: total bilirubin: 1.5 mg/dl, AST(aspartate aminotransferase)/ALT (alanine transaminase): 2 times normal, Alkaline phosphatase:2 times normal
Written informed consent
Normal mental function to understand and sign the consent
Cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment.
LVEF (left ventricular ejection fraction)50% by MUGA (multiple gated acquisition scan) or Echocardiogram taken within 1 mo of enrollment
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Byeong Woo Park, MD, PhD | Contact | 82-2-2228-8125 | nobelg@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Byeong Woo Park, MD, PhD | Severance Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| up to 3 years |
| The percentage of patients who receive breast conserving surgery. | To assess the percentage of patients who receive breast conserving surgery within total triple negative breast cancer patients | up to 3years |
| Number of adverse events | Number of adverse events in patients with non-pCR. | up to 3years |
| D017437 |
| Skin and Connective Tissue Diseases |