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RECRUITING
NCT05901428
PHASE3

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

1736

Start Date

2023-06-01

Completion Date

2028-06

Last Updated

2023-06-15

Healthy Volunteers

No

Interventions

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.

Locations (1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China