A Phase III Trial of Carboplatin as Adjuvant Chemotherapy in Triple Negative Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase III Trial of Carboplatin as Adjuvant Chemotherapy Versus Observation in Triple Negative Breast Cancer With Pathologic Residual Cancer After Neoadjuvant Chemotherapy: POST-Neo Adjuvant Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of breast cancer Female patients Histologically confirmed invasive breast cancer Primary tumor greater than 2cm diameter, measured by mammography and sonography Any N 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: Patients who received hormonal, chemotherapy or radiotherapy for breast cancer Patients who underwent surgery for breast cancer Patients with a history of uncompensated congestive heart failure Patients with inflammatory breast cancer (T4d) Patients without primary tumor (T0) Patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer Known hypersensitivity to any of the study drugs

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: carboplatin chemotherapy<br>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. | Drug: carboplatin<br>* carboplatin as adjuvant chemotherapy<br>* Other names: Adding adjuvant arm;|
| No Intervention: Observation arm<br>In this observation arm, patients should be follow up with regular interval without treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Triple negative breast cancer, adjuvant chemotherapy