RecruitingPhase 3NCT05883852

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

Sponsor

Fudan University

Enrollment

1,406 participants

Start Date

Jun 7, 2023

Study Type

INTERVENTIONAL

Conditions

HER2 Positive Early Breast Cancer

Summary

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

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different chemotherapy regimens used after surgery for HER2-positive breast cancer that has spread to the lymph nodes — one regimen (EC-THP) versus another (TCbHP) — to see which works better and is safer. **You may be eligible if...** - You are a woman between 18 and 70 years old - You have been diagnosed with HER2-positive breast cancer (confirmed by pathology) - Your cancer has spread to the lymph nodes (stage pT1–4, N1–3) - You have had surgery and all visible cancer was removed - You have not received chemotherapy before surgery (no neoadjuvant therapy) - You are starting treatment within 8 weeks of surgery - You have no significant nerve damage in your hands or feet **You may NOT be eligible if...** - You have received any adjuvant therapy after surgery already - You have poor organ function (heart, liver, kidneys) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDocetaxel

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

DRUGcarboplatin

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

DRUGTrastuzumab

Trastuzumab is a humanized monoclonal antibody derived from recombinant DNA,

DRUGPertuzumab

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

DRUGEpirubicin

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.

DRUGcyclophosphamide

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

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NCT05883852