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Clinical Trial Summary

This is an open-label, single arm, two-stage Simon Design study for women with LuminalB/HER-2 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 Nanoparticle Albumin-Bound Paclitaxel Combined with Carboplatin as Neoadjuvant Chemotherapy in Luminal B/HER-2 Negative Breast Cancer.

The primary endpoint of the study is 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 78 patients.

The duration of the study, from first patient visit to last patient visit will be approximately 12 months.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03799692
Study type Interventional
Source Fudan University
Contact Zhimin Shao
Phone 18017312288
Email szm@163.com
Status Recruiting
Phase Phase 4
Start date November 19, 2018
Completion date July 30, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT05761470 - Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation Phase 2
Not yet recruiting NCT05398861 - Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer Phase 2