TA(E)C-GP Versus A(E)C-T for the High Risk TNBC Patients and Validation of the mRNA-lncRNA Signature

Phase 2/3 Active not recruiting 503 enrolled Fudan University

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the efficacy and safety between docetaxel combined with doxorubicin (epirubicin) and cyclophosphamide followed by gemcitabine combined with cisplatin and doxorubicin (epirubicin) combined with cyclophosphamide followed by docetaxel for high risk triple negative breast cancer predicted by the mRNA-lncRNA integrated signature and validation the efficacy of the signature.

Timeline

Start: 2016-01
Primary completion: 2023-12
Completion: 2027-12

Outcome

Met primary endpoint

paper arm A and 80.6% for patients in arm B (hazard ratio 0.51, 95% confidence interval (CI) 0.28 to 0.95; P=0.03). PMID 39442958 ↗

Publications

He M, Jiang YZ, Gong Y, Fan L, Liu XY, Liu Y, Tang LC, Mo M, Hou YF, Di GH, Liu GY, Yu KD, Wu J, Yan X, Zeng XH, Fu DY, Song CG, Zhuang ZG, Wu KJ, Wang J, Wang ZH, Shao ZM. Intensive chemotherapy versus standard chemotherapy among patients with high risk, operable, triple negative breast cancer based on integrated mRNA-lncRNA signature (BCTOP-T-A01): randomised, multicentre, phase 3 trial. BMJ. 2024 Oct 23;387:e079603. doi: 10.1136/bmj-2024-079603.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Subject	Cyclophosphamide	Other / unclassified	500 mg/m2	Intravenous
Subject	Cyclophosphamide	Other / unclassified	600 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	100 mg/m2	Intravenous
Subject	Doxorubicin	Other / unclassified	50 mg/m2	Intravenous
Subject	Doxorubicin	Other / unclassified	60 mg/m2	Intravenous
Subject	Epirubicin	Small molecule	75 mg/m2	Intravenous
Subject	Epirubicin	Small molecule	90 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1250 mg/m2	Intravenous