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Comparison Study of Adjuvant Chemotherapy for Chinese Triple Negative Breast Cancer

Expanded access is currently available for this treatment.
Verified June 2010 by Fudan University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01216111
First Posted: October 7, 2010
Last Update Posted: October 7, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Chinese Anti-Cancer Association
Information provided by:
Fudan University
October 6, 2010
October 7, 2010
October 7, 2010
 
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)

Expanded Access
Drug: Paclitaxel Cisplatin

Paclitaxel 100 mg/m2 D1,8,15 Cisplatin AUC=2 D1,8,15

1 cycle = 28days

PC*6

 
Available
Contact: Zhimin Shao, MD, PHD +862164175590 ext 8708 luona801379@hotmail.com
Contact: Fei Fei, MD +862164175590 ext 8700 baketutu520@gmail.com
Not Provided
 
 
NCT01216111
Chinese Anti-Cancer Association,Committee Breast Cancer Society
Fudan University
Chinese Anti-Cancer Association
Not Provided
Fudan University
June 2010