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RECRUITING
NCT05883852
PHASE3

EC-THP Versus TCbHP in HER2-positive Lymph Node Positive Early Breast Cancer

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients

Official title: A Randomized Controlled, Phase III Trial in HER2-positive Lymph Node Positive Early Breast Cancer to Compare the Efficacy and Safety of Epriubin Plus Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and Pertuzumab (EC-THP) Versus Docetaxel and Carboplatin Plus Trastuzumab and Pertuzumab (TCbHP) in the Adjuvant Treatment

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

1406

Start Date

2023-06-07

Completion Date

2031-07-01

Last Updated

2023-06-27

Healthy Volunteers

No

Interventions

DRUG

Docetaxel

Docetaxel is a taxoid antineoplastic agent used in the treatment of breast cancer

DRUG

carboplatin

Carboplatin is a DNA synthesis inhibitor which binds to DNA, inhibits replication and transcription and induces cell death.

DRUG

Trastuzumab

Trastuzumab is a humanized monoclonal antibody derived from recombinant DNA,

DRUG

Pertuzumab

Pertuzumab is a recombinant humanized monoclonal antibody that specifically binds to the extracellular dimerization domain (subdomain Ⅱ) of epidermal growth factor receptor 2(HER2).

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

An anticancer (antitumor or cytotoxic) chemotherapy drug that is classified as an alkylating agent. Alkylating agents are compounds that prevent the normal connection of the double helix chain by adding an alkyl group to the guanine base of the DNA molecule. It causes breaks in DNA strands, affecting the ability of cancer cells to proliferate.

Locations (1)

Fudan University Shanghai Cancer Center Shanghai, China, 200032

Shanghai, Shanghai Municipality, China