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

Primary Purpose

HER2 Positive Early Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Docetaxel
carboplatin
Trastuzumab
Pertuzumab
Epirubicin
cyclophosphamide
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HER2 Positive Early Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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。

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A:TCbHP

Arm B:EC-THP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

iDFS
invasive Disease Free Survival

Secondary Outcome Measures

DRFS
distant relapse free survival
OS
overall survival
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of treatment-emergent adverse events adverse events according to CTCAE 5.0

Full Information

First Posted
May 20, 2023
Last Updated
June 23, 2023
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05883852
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
July 1, 2031 (Anticipated)
Study Completion Date
July 1, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2 Positive Early Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1406 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A:TCbHP
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B:EC-THP
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel is a taxoid antineoplastic agent used in the treatment of breast cancer
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
Carboplatin is a DNA synthesis inhibitor which binds to DNA, inhibits replication and transcription and induces cell death.
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Intervention Description
Trastuzumab is a humanized monoclonal antibody derived from recombinant DNA,
Intervention Type
Drug
Intervention Name(s)
Pertuzumab
Intervention Description
Pertuzumab is a recombinant humanized monoclonal antibody that specifically binds to the extracellular dimerization domain (subdomain Ⅱ) of epidermal growth factor receptor 2(HER2).
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
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 Measure Information:
Title
iDFS
Description
invasive Disease Free Survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
DRFS
Description
distant relapse free survival
Time Frame
5 years
Title
OS
Description
overall survival
Time Frame
5 years
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Incidence of treatment-emergent adverse events adverse events according to CTCAE 5.0
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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。
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center Shanghai, China, 200032
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhimin Shao, M.D.
Phone
+86-021-64175590
Ext
88807
Email
zhimingshao@yahoo.com
First Name & Middle Initial & Last Name & Degree
Linxiaoxi Ma, M.D
Phone
+86-021-64175590
Ext
63169
Email
mary2008white@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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