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Clinical Trial Summary

This is an open-label, single arm, two-stage Simon Design study for women with Triple Negative Breast Cancer treated with Nanoparticle Albumin-Bound Paclitaxel and Carboplatin.

The primary objective of the trial is to evaluate of the efficacy and safety of weekly Nanoparticle Albumin-Bound Paclitaxel(Nab-P) Followed by Dose-Intensive Epirubicin in Combination with Cyclophosphamide as Neoadjuvant Chemotherapy in Triple Negative Breast Cancer.

The primary endpoint of the study is to to assess Pathological complete response rate(pCR)using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)..

The total number of patients to be included in this study is 60 patients.

The duration of the study, from first patient visit to last patient visit will be approximately 19 months.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03799679
Study type Interventional
Source Fudan University
Contact Zhimin Shao
Phone 18017312288
Email szm@163.com
Status Recruiting
Phase Phase 4
Start date November 26, 2018
Completion date February 1, 2020

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