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

ConditionHER2 Positive Early Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFudan University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged 18-70；

0-1 for ECOG；

Unilateral invasive carcinoma confirmed by histology (regardless of pathological type)；

No gross or microscopic tumor remains after surgical resection；

Disqualifiers

Bilateral breast cancer or carcinoma in situ DCIS/LCIS；

Have received chemotherapy for advanced disease；

Transfer of any part；

If any tumor >T4a (accompanied by skin invasion, mass adhesion fixation, inflammatory breast cancer)；

Trial design

Design model

Parallel

Treatments tested in this trial

  • Docetaxel

    Drug

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

  • carboplatin

    Drug

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

  • Trastuzumab

    Drug

    Trastuzumab is a humanized monoclonal antibody derived from recombinant DNA,

  • Pertuzumab

    Drug

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

  • Epirubicin

    Drug

    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.

  • cyclophosphamide

    Drug

    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.

Treatment groups

1,406 Participants
are divided into 2 treatment groups
Group A: Arm A：TCbHPExperimental treatment 4 interventions
Group B: Arm B：EC-THPActive comparator 5 interventions

Trial outcomes

Primary outcomes

1

iDFS

invasive Disease Free Survival

Time frame
5 years

Secondary outcomes

1

DRFS

distant relapse free survival

Time frame
5 years
2

OS

overall survival

Time frame
5 years
3

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Incidence of treatment-emergent adverse events adverse events according to CTCAE 5.0

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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