Phase IIb Trial of Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Epirubicin as Neoadjuvant Treatment in Locally Advanced Triple-negative Breast Cancer
It is know that triple-negative breast cancer(TNBC) is more aggressive than non-triple
negative breast cancer in both pathological features and clinical prognosis,and there is no
standard chemotherapy regimens especially for TNBC. NCCN guidelines recommends Paclitaxel or
Epirubicin based regimens as the preferred regimens both for the adjuvant chemotherapy and
the treatment of Recurrence and Metastatic breast cancer.The combination of these two drugs
is considered as a strong arrangement and therefore,is common used in Triple negative breast
cancer patients because of its poor prognosis.
According to the results of some retrospective studies, platinum-based chemotherapy
regimens showed a promising sensitive to Triple negative breast cancer patients compared
with regimens without platinum.
This study is to compare the effective of Paclitaxel combined with Epirubicin and Paclitaxel
plus Carboplatin in the neoadjuvant treatment for TNBC. And the investigators hypothesized
that paclitaxel combined with carboplatin is more sensitive to TNBC compared with Paclitaxel
plus Epirubicin,this study will also have a look into the relation of BRCA1 mutation and
sensitive to carboplatin.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathology of specimens derived from the breast modified radical mastectomy/Breast-conserving surgery
After patients complete the neoadjuvant chemothreapy and receive the surguries,we can get their pathology ,and compare the pCR(pathological complete remission)rates of two amrs
One week after the surgery
Yes
ZHANG Pin, BD
Principal Investigator
Cancer Institute Hospital, Chinese Academy of Medical Sciences
China: Ethics Committee
LC2010A03
NCT01276769
January 2008
July 2012
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