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Achievement of pathologic complete response is important prognosticator to predict long term outcome in triple negative cancer. The efficacy of adding 4 cycles of cisplatin (CDDP4) is to be investigated whether addtional pathologic complete response is achieved for those triple negative breast cancer patients who recieved 4 cycles of adriamycin with cyclophosphamide(AC4) but did not reach clinical complete response during the course of neoadjuvant therapy.
First outcome measures (analysis) :at the time of surgery,
Second outcome measures:
2019 August, 5 year Overall Survival, Disease free survival
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adriamycin,cytoxan, cisplatin | Experimental | 4 cycles of Adriamycin 60 mg/m2 and Cyclophosphamide 600 mg/m2 every 3 weeks followed by 4 cycles of cisplatin 75 mg/m2 every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC4-CDDP4 | Drug | 4 cycles of Adriamycin 60 mg/m2 and Cyclophosphamide 600 mg/m2 every 3 weeks 4 cycles of cisplatin 75 mg/m2 every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| pathologic complete response (pCR) rate | Rate of pCR (as defined by NSABP [National Surgical Adjuvant Breast and Bowel Project] criteria - absence of invasive disease in the breast [ypT0]) at the time of surgery. | up to 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) by radiologic evaluation | after completion of chemotherapy Overall objective clinical response rate = CR (complete response) + PR (partial response) rate, measured by US (or MRI) and assessed by Response Evaluation Criteria in Solid Tumors (RECIST) | up to 36 weeks |
| Complete metabolic response (CMR) rate after 2 cycles of AC |
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Inclusion Criteria:
Patients with histologically proven breast cancer
Age, at least 20 years
ER/PR/HER2 (negative/negative/negative
Clinically stage II or III with histologically proven lymph-node involvement (T >1.5 cm or lymph node [LN] >1.5 cm)
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
No prior hormonal treatment, chemotherapy or radiotherapy is allowed.
Adequate hematologic, liver and kidney function
Written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sung-Bae Kim | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 138-736 | South Korea |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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after 2 cycles of AC |
| up to 12 weeks |
| 3 year disease free survival (3yr-DFS) | 3 years |
| Rate of breast conservation | after surgery | up to 36 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |