NCT05901428

TCb vs EC-T in High Risk ER+/HER2- Breast Cancer

A Randomized, Open-label, Single-center, Phase III Trial Comparing Docetaxel Plus Carboplatin (TCb) Versus Epirubicin Plus Cyclophosphamide Followed by Docetaxel (EC-T) Regimen as Adjuvant Chemotherapy in Patients With LN≥4 Estrogen Receptor Positive and Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Breast Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,736 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of docetaxel plus carboplatin (TCb) regimen compared with conventional chemotherapy regimen (epirubicin plus cyclophosphamide followed by docetaxel, EC-T) regimen as adjuvant chemotherapy in patients with early-stage high-risk estrogen receptor (ER) positive and human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.

Conditions

• Hormone Receptor Positive HER-2 Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel is a taxoid antineoplastic agent used in the treatment of breast cancer
DRUG	Carboplatin	Carboplatin is a deoxyribonucleic acid (DNA) synthesis inhibitor which binds to DNA, inhibits replication and transcription and induces cell death.
DRUG	Epirubicin	Epirubicin is an antineoplastic agent derived from doxorubicin.Epirubicin, like doxorubicin, exerts its antitumor effects by interference with the synthesis and function of DNA and is most active during the S phase of the cell cycle.
DRUG	Cyclophosphamide	Cyclophosphamide is a nitrogen mustard that exerts its anti-neoplastic effects through alkylation.

Timeline

• Start date: 2023-06-01
• Primary completion: 2026-06-01
• Completion: 2028-06-01
• First posted: 2023-06-13
• Last updated: 2023-06-15

Locations

1 site across 1 country: China