Breast Cancer Clinical Trial
Official title:
A Prospective, Single-Arm Study to Evaluate the Efficacy and Safety of Abraxane Combined With Epirubicin as Neoadjuvant Chemotherapy in Early Operable Breast Cancer
Some studies have demonstrated the efficacy of Abraxane in treating breast cancer in both
adjuvant and metastatic settings. Few data is available on Abraxane in neoadjuvant treatment
for breast cancer.
The aim of this project is to evaluate tailored primary systemic therapy with weekly Abraxane
(125mg/m2) Combined With Q3week Epirubicin (100mg/m2) in early operable (stage of T2-4N0-3M0)
breast cancer. This study will be an open label non randomized, single arm, single center
study.
The hypothesis is that tailored neoadjuvant chemotherapy with 4 cycles of PE(weekly Abraxane
125mg/m2, Q3week Epirubicin 100mg/m2, 21day/cycle) is feasible and achieves high response
rates.
It is proposed that 50 patients will be enrolled in this study. The target population is
women with early breast cancer (stage of T2-4N0-3M0) who are eligible for primary systemic
therapy.
The primary objective of the trial is to determine the overall response rate. Secondary
endpoints will include response rates in axillary lymph nodes, safety and tolerability and
the rate of breast conservation.
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