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A Study to Evaluate Gemcitabine Plus Cisplatin in the Treatment of TNBC Patients Following Neoadjuvant Chemotherapy — nonpCR GP  

Triple Negative Breast Cancer Clinical Trial

Official title:
A Prospective, Single Arm, Multicenter, Phase II Trial of Gemcitabine Plus Cisplatin in the Treatment of Patients With Non-pCR Triple Negative Breast Cancer Following Neoadjuvant Chemotherapy

Clinical Trial Summary

This is a prospective, open-lable phase II clinical trial evaluating the effectiveness and safety of gemcitabine plus cisplatin as adjuvant treatment for non-pCR TNBC patients after standard neoadjuvant chemotherapy.

Clinical Trial Description

This is a prospective, open-lable phase II clinical trial evaluating the effectiveness and safety of gemcitabine plus cisplatin as adjuvant treatment for non-pCR TNBC patients after standard neoadjuvant chemotherapy. Non-pCR TNBC patients who completed 6-8 cycles of standard neoadjuvant chemotherapy will be included in this study and receive 4 cycles of GP regimen chemotherapy(cisplatin 75 mg/m² d1 and gemcitabine 1250 mg/m² d1,8, every 3 weeks). Our primary endpoint is disease free survival (DFS). Secondary end points include overall survival (OS), recurrence free survival (RFS), distant disease free survival (DDFS)rates and safety. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04297267
Study type Interventional
Source Fudan University
Contact
Status Active, not recruiting
Phase Phase 2
Start date February 7, 2017
Completion date June 30, 2023
View Details
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