NCT05883852

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,406 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The objective of this study is to conduct a randomized controlled clinical study to compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients, so as to further optimize adjuvant chemotherapy regimen for breast cancer.

Conditions

• HER2 Positive Early 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 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.

Timeline

• Start date: 2023-06-07
• Primary completion: 2031-07-01
• Completion: 2031-07-01
• First posted: 2023-06-01
• Last updated: 2023-06-27

Locations

1 site across 1 country: China