Additional 4 Cycles of Cisplatin (CDDP4) in Patients With Triple Negative Breast Cancer for Neoadjuvant Chemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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First outcome measures (analysis) :at the time of surgery, Second outcome measures: 2019 August, 5 year Overall Survival, Disease free survival

Official Title
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A Phase ll Trial of Impact of Additional 4 Cycles of Cisplatin (CDDP4) in Patients With Triple Negative Breast Cancer Not Achieving Clinical CR After 4 Cycles of Neoadjuvant Adriamycin Plus Cyclophosphamide

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: AC4-CDDP4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically proven breast cancer Age, at least 20 years ER/PR/HER2 (negative/negative/negative ER/PR negative: nuclear reaction < 1%, Allred score 0 or 2 HER2 negative: HER2; IHC (immunohistochemistry) 0,1+ or FISH/SISH (-) in case of IHC 2+ 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: Pregnancy or lactation Prior chemotherapy or radiotherapy for any malignancy Stage T4d; inflammatory breast cancer No primary tumor (T0) Documented history of cardiac disease contraindicating anthracyclines Currently active infection

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: adriamycin,cytoxan, cisplatin<br>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 | Drug: AC4-CDDP4<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |