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Comparison of TP and TAC Regimens in Neoadjuvant Treatment of TNBC

Triple Negative Breast Cancer Clinical Trial

Official title:
Comparing TP (Docetaxel + Cisplatin) and TAC (Docetaxel + Doxorubicin + Cyclophosphamide) in Neoadjuvant Therapy for Operable Triple Negative Breast Cancer, A Multicenter, Randomized, Phase II Clinical Trial

Clinical Trial Summary

Previous studies have shown that TNBC is sensitive to DNA crosslinking-related chemotherapeutic drugs such as platinum. However, there is a lack of large sample prospective clinical data to compare the efficacy of TP and EC-T / TEC regimen in the neoadjuvant chemotherapy of TNBC. Besides, the application of anthracycline drugs is limited to a certain extent due to the cardiotoxicity. Based on the above evidence, the researchers hope to explore a more effective and safer new adjuvant therapy for TNBC.

Clinical Trial Description

In this study, TNBC patients were randomly divided into experimental group and control group, the ratio of experimental group to control group was 1:1. The experimental group received 6 cycles of neoadjuvant chemotherapy (docetaxel 75 mg / m2 day 1 + cisplatin 25 mg / m2 day 1, 2, 3), 21 days as a cycle. The control group was treated with TAC (docetaxel 75mg / M2 + adriamycin 50mg / M2 + cyclophosphamide 500mg / m2) for 6 cycles, 21 days as a cycle. To compare the efficacy and safety of 6*TP (docetaxel + cisplatin) regimen and traditional 6*TAC (docetaxel + doxorubicin + cyclophosphamide) regimen in neoadjuvant chemotherapy of TNBC. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04664972
Study type Interventional
Source Henan Cancer Hospital
Contact
Status Completed
Phase Phase 2
Start date November 23, 2018
Completion date November 26, 2022
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