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
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.
|Condition or disease||Intervention/treatment|
|Triple Negative Breast Cancer||Drug: Paclitaxel Cisplatin|
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|
|Official Title:||A Prospective， Randomized， Open-label， Multicentric，phaseIII Clinical Trial Compared With PC and CEF100 Followed by Docetaxel as Adjuvant Chemotherapy Regimen for Chinese Primary Triple Negative Breast Cancer Patients|
Drug: Paclitaxel Cisplatin
Paclitaxel 100 mg/m2 D1，8，15 Cisplatin AUC=2 D1，8，15
1 cycle = 28days
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01216111
|Contact: Zhimin Shao, MD, PHD||+862164175590 ext firstname.lastname@example.org|
|Contact: Fei Fei, MD||+862164175590 ext email@example.com|