Overview

Albumin-Bound Paclitaxel Followed by Epirubicin in Combination With Cyclophosphamide in Triple Negative Breast Cancer

Status:
Unknown status

Trial end date:
2020-02-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 4

Details

Lead Sponsor:

Fudan University

Treatments:

Albumin-Bound Paclitaxel
Antineoplastic Agents
Cyclophosphamide
Epirubicin
Paclitaxel