compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,406
Docetaxel is a taxoid antineoplastic agent used in the treatment of breast cancer
Carboplatin is a DNA synthesis inhibitor which binds to DNA, inhibits replication and transcription and induces cell death.
Trastuzumab is a humanized monoclonal antibody derived from recombinant DNA,
Fudan University Shanghai Cancer Center Shanghai, China, 200032
Shanghai, Shanghai Municipality, China
RECRUITINGiDFS
invasive Disease Free Survival
Time frame: 5 years
DRFS
distant relapse free survival
Time frame: 5 years
OS
overall survival
Time frame: 5 years
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
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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 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.
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.