Comparison Study of Adjuvant Chemotherapy for Chinese Triple Negative Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01216111|
Recruitment Status : Available
First Posted : October 7, 2010
Last Update Posted : October 7, 2010
|First Submitted Date||October 6, 2010|
|First Posted Date||October 7, 2010|
|Last Update Posted Date||October 7, 2010|
|Brief Title||Comparison Study of Adjuvant Chemotherapy for Chinese Triple Negative Breast Cancer|
Previous studies in Western country show that triple-negative breast cancer has aggressive clinical and pathological features compared with non-triple negative breast cancer, including onset at a young age, advanced clinical stage, high histologic and nuclear grade and more distant recurrence.
According to the characteristics of triple negative breast tumor, the TNBC patients can benefit neither from hormonal therapies nor from target therapies against Her2 receptors. The only systemic therapy currently available is chemotherapy, and prognosis remains poor. It becomes more and more important to investigate the sensitive chemotherapy regimen for triple negative patients.
Cisplatin-based regimen was active for the patients of lung cancer, colorectal cancer and ect. Triple negative breast cancer patients were more sensitive to platinum-based chemotherapy regimens according to the results of some retrospective studies.
The investigators hypothesized that paclitaxel combined with cisplatin is more sensitive to triple negative breast cancer compared with CEF followed by docetaxel.
Eligibility Female adults(>18 years old) are eligible if they had histologically confirmed primary breast cancer. Patients also had Eastern Cooperative Oncology Group(ECOG) Performance status of 0 or 1, absolute neutrophil count (ANC)>1500/mm3,hemoglobin >8.0g/dL, and platelet count >100,000/mm3,creatinine<2.5 times the upper limit of normal(ULN)）, transaminases<2.5 times ULN or alkaline phosphatase<4 times ULN if transaminases was normal, and total bilirubin <2.5 times ULN. Exclusion criteria were active infection, pregnancy, other primary malignancy (except in situ carcinoma of cervix or adequately treated nonmelanomatous carcinoma of the skin), any documented distant metastasis and uncontrolled systemic diseases.
This study protocol was approved by institutional ethic review boards and conducted according to guidelines for good clinical practice and the Helsinki Declaration.All patients provided written informed consent.
Outcome Measures Primary Endpoint：5 year Disease Free Survival（DFS） Second Endpoints：5 year distant disease free survival （DDFS） 5 year event free survival （EFS） 5 year overall survival （OS）
|Study Type||Expanded Access|
|Intervention||Drug: Paclitaxel Cisplatin
Paclitaxel 100 mg/m2 D1，8，15 Cisplatin AUC=2 D1，8，15
1 cycle = 28days
|Expanded Access Status||Available|
|Listed Location Countries||Not Provided|
|Removed Location Countries|
|Responsible Party||Chinese Anti-Cancer Association，Committee Breast Cancer Society|
|Study Sponsor||Fudan University|
|Collaborators||Chinese Anti-Cancer Association|
|PRS Account||Fudan University|
|Verification Date||June 2010|