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

June 23, 2023 updated by: Zhimin Shao, Fudan University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1406

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center Shanghai, China, 200032
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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。

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A：TCbHP
Docetaxel 75mg/m2 ivgtt d1+ carboplatin AUC=6 ivgtt d1+ trastuzumab first dose 8mg/kg (maintain 6mg/kg) d1 ivgtt d1+ Pertuzumab first dose 840mg (maintain 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year.
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).
Active Comparator: Arm B：EC-THP
Epirubicin 90 mg/m2 ivgtt d1+ cyclophosphamide 600 mg/m2 iv d1, 3 weeks of treatment, a total of 4 courses; Docetaxel 100mg/m2 ivgtt d1+ trastuzumab first dose 8mg/kg (maintenance 6mg/kg) d1 ivgtt d1+ pertuzumab first dose 840mg (maintenance 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year.
Drug: Docetaxel
Docetaxel is a taxoid antineoplastic agent used in the treatment of breast cancer
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
iDFS
Time Frame: 5 years
invasive Disease Free Survival
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 5 years
overall survival
5 years
DRFS
Time Frame: 5 years
distant relapse free survival
5 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: through study completion, an average of 1 year
Incidence of treatment-emergent adverse events adverse events according to CTCAE 5.0
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2023

Primary Completion (Estimated)

July 1, 2031

Study Completion (Estimated)

July 1, 2031

Study Registration Dates

First Submitted

May 20, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCHBCC-N055

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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