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

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

Overview

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.

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.

Primary outcome measures

• iDFS [Time frame: 5 years]

Secondary outcome measures (3)

• DRFS [Time frame: 5 years]
• OS [Time frame: 5 years]
• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

• 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；
• Early breast cancer, pathologically confirmed as HER2 positive; HER2 positive definition: Immunohistochemical HER2 3+ or FISH/CISH test positive (with amplification) is defined as HER2 positive；
• Postoperative pathological stage pT1-4N1-3M0；
• Did not receive neoadjuvant chemotherapy in the past；
• The longest period from surgery to randomization was not more than 8 weeks, and no adjuvant therapy had been received after surgery；
• No peripheral neuropathy；
• Good postoperative recovery, at least 1 week interval between operation；
• The major organs function normally, that is, meet the following criteria: (1) The standard of blood routine examination shall meet: HB ≥90 g/L (no blood transfusion within 14 days); ANC ≥1.5×109 /L; PLT ≥100×109 /L; (2) Biochemical examination should meet the following standards: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3 x ULN; Serum Cr ≤1.5×ULN；
• Contraception during treatment for women of reproductive age；
• Cardiac function: LVEF>50% for ultrasound examination；
• The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up。

Exclusion criteria

• 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)；
• Patients with clinical or imaging suspicion of malignancy on the opposite breast but not confirmed, requiring biopsy；
• Have received neoadjuvant therapy, including chemotherapy, radiotherapy and endocrine therapy；
• Malignant neoplasms (other than basal cell carcinoma of the skin and carcinoma in situ of the cervix), including contralateral breast cancer, within the previous 5 years；
• The patient has been enrolled in other clinical trials；
• Patients with severe systemic disease and/or uncontrolled infection were unable to be enrolled in the study；
• LVEF<50% (cardiac ultrasound)；
• Severe cardiovascular and cerebrovascular disease (e.g., unstable angina, chronic heart failure, uncontrolled hypertension >150/90mmgh, myocardial infarction or cerebrovascular accident) within 6 months prior to randomization；
• Known allergy to related drugs；
• Women of childbearing age refuse contraception during treatment and within 8 weeks after completion of treatment；
• Pregnant and lactating women；
• Those who tested positive for pregnancy before taking the drug after joining the trial；
• Mental illness, cognitive impairment, inability to understand the trial protocol and side effects, inability to complete the trial protocol and follow-up workers ；(systematic evaluation is required before trial enrollment)；
• Persons without personal freedom and independent capacity for civil conduct。

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Fudan University Shanghai Cancer Center Shanghai, China, 200032 — Shanghai

Identifiers

NCT: NCT05883852 · SCHBCC-N055

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗