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Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer

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ClinicalTrials.gov Identifier: NCT03433313
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
EirGenix, Inc.

Tracking Information
First Submitted Date  ICMJE February 8, 2018
First Posted Date  ICMJE February 14, 2018
Last Update Posted Date May 3, 2019
Actual Study Start Date  ICMJE October 16, 2018
Estimated Primary Completion Date August 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
Determination of pathologic complete response (pCR) at time of surgery [ Time Frame: At the time of surgery (3-6 weeks after completion of neoadjuvant chemotherapy) ]
pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled sentinel and/or axillary lymph nodes
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2018)
Determination of pathologic complete response (pCR) [ Time Frame: 3 to 6 weeks after completion of neoadjuvant chemotherapy ]
pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled sentinel and/or axillary lymph nodes
Change History Complete list of historical versions of study NCT03433313 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
  • pCR at the time of surgery [ Time Frame: At the time of surgery (3-6 weeks after completion of neoadjuvant chemotherapy) ]
    pCR is defined as the absence of residual invasive cancer and of DICS (ypT0 ypN0) from breast tissue and sentinel/axillary lymph nodes, as assessed by central laboratory
  • pCR at the time of surgery [ Time Frame: At the time of surgery (3-6 weeks after completion of neoadjuvant chemotherapy) ]
    pCR is defined as the absence of invasive cancer in breast tissue only (ypT0/is) as assessed by central laboratory
  • Event-free survival (EFS) up to end of study (EOS) [ Time Frame: Randomization to date of progression or end of study (up to approximately 24 months or death) ]
    EFS is defined as time from initial randomization to the date when disease recurrence or progression (local, regional, distant or contralateral) is diagnosed according to institutional standard, or date of death of any cause, whichever is earlier
  • Overall response (OR) prior to surgery [ Time Frame: At screening and prior to surgery (3-6 weeks after completion of neoadjuvant chemotherapy) ]
    Objective response is defined as partial response (PR) or complete response (CR) according to RECIST v1.1
  • Overall survival (OS) up to End of Study (EOS) [ Time Frame: Randomization to end of study (up to approximately 24 months or death) ]
    OS up to EOS is defined as time from the date of initial randomization to the date of death
  • Incidence of AEs [ Time Frame: From time of informed consent to end of study (up to approximately 25 months or death) ]
    Incidence of AEs (including severity, seriousness, and relationship to study drug) and laboratory abnormalities
  • Evaluation of Immunogenicity of EG12014 and Herceptin [ Time Frame: Prior to 1st infusion of study drug, during neoadjuvant treatment, after the last dose of neoadjuvant treatment, during adjuvant treatment, and End of Treatment ]
    Titer of anti-drug antibodies (ADA)
  • Measure serum trastuzumab concentration [ Time Frame: Prior to 1st infusion of study drug, during neoadjuvant treatment after the last dose of neoadjuvant treatment, during adjuvant treatment, and End of Treatment ]
    Measure serum trastuzumab concentration for EG12014 and Herceptin arms
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer
Official Title  ICMJE A Phase III, Randomized, Multicenter, Double-blind Study to Compare Efficacy and Safety of EG12014 With Herceptin as Neoadjuvant Treatment in Combination With Anthracycline/Paclitaxel Systemic Therapy in HER2-Positive Early Breast Cancer
Brief Summary The purpose of this research study is to compare the efficacy and safety of EG12014 with Herceptin as neoadjuvant treatment for 12 weeks, followed by surgery and subsequent EG12014 or Herceptin adjuvant treatment for up to 12 months.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: EG12014
    EG12014 6mg/kg is ongoing to be administered after 8mg/kg loading dose.
  • Drug: Herceptin
    Herceptin 6mg/kg is ongoing to be administered after 8mg/kg loading dose.
Study Arms  ICMJE
  • Experimental: EG12014
    Epirubicin and cyclophosphamide followed by EG12014 plus paclitaxel. All patients will be scheduled for surgery (breast and axillary lymph nodes) at 3 to 6 weeks after completion of neoadjuvant chemotherapy.
    Intervention: Drug: EG12014
  • Active Comparator: Herceptin
    Epirubicin and cyclophosphamide followed by Herceptin plus paclitaxel. All patients will be scheduled for surgery (breast and axillary lymph nodes) at 3 to 6 weeks after completion of neoadjuvant chemotherapy.
    Intervention: Drug: Herceptin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 8, 2018)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 13, 2021
Estimated Primary Completion Date August 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Provide signed and dated written informed consent before entering the study. The informed consent will cover both parts of the study (neoadjuvant part and adjuvant part).
  2. Female, ≥18 and ≤65 years of age.
  3. Histologically-confirmed invasive carcinoma of the breast
  4. Operable breast cancer, planned surgical resection of breast tumor (mastectomy or lumpectomy) and sentinel or axillary lymph nodes.
  5. Ipsilateral, measurable tumor of the breast ≥2 cm in diameter.
  6. HER2 positive tumor
  7. Known estrogen receptor (ER) and progesterone receptor (PrR) status at study entry.
  8. Adequate bone marrow function
  9. Adequate hepatic and renal function
  10. International normalized ratio ≤1.5×ULN (2 to 3×ULN if on anticoagulants) or prothrombin time ≤1.5×ULN; activated partial thromboplastin time ≤1.5×ULN.
  11. Hemoglobin concentrations within the normal ranges.
  12. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
  13. LVEF ≥55%, measured by multiple-gated acquisition (MUGA) scan or echocardiography.
  14. Negative pregnancy test at entry, women of childbearing potential have to use contraceptives during the course of the study.

Exclusion Criteria:

  1. Bilateral breast cancer.
  2. Pregnancy or lactation or considering becoming pregnant.
  3. Metastases, other than sentinel/axillary lymph nodes.
  4. Previous treatment (chemotherapy, biologic therapy, radiation, or surgery) for invasive malignant disease or other concomitant active malignancy, other than basal cell carcinoma of the skin. Previous treatment for carcinoma in situ of the cervix is allowed.
  5. Other serious illness or medical disorder.
  6. Previous treatment with Herceptin.
  7. Angina pectoris or arrhythmia requiring medication; poorly controlled hypertension; left ventricular hypertrophy on echocardiography; history of myocardial infarction or cardiac failure, New York Heart Association (NYHA) class II or higher; clinically significant cardiac valvular disease; hemodynamic effective pericardial effusion; other cardiomyopathies; coronary artery disease; LVEF of <55%.
  8. Any investigational treatment less than 30 days prior to study entry, or within a time interval less than at least 5 half-lives of the investigational medicinal product, whichever is longer.
  9. Positive diagnostic test for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
  10. History of hypersensitivity to the study drug or to drugs with similar chemical structures.
  11. History of, or known current problems with, drug or alcohol abuse.
  12. Other serious illness, medical disorder or condition that, in the opinion of the Investigator, would make the patient unsuitable for participation in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Udo Kiessling, MD PhD +49 176 61901762 udo.kiessling@eirgenix.com
Listed Location Countries  ICMJE Belarus,   Chile,   Colombia,   Georgia,   India,   Korea, Republic of,   Russian Federation,   South Africa,   Taiwan,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03433313
Other Study ID Numbers  ICMJE EGC002
2017-003973-33 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party EirGenix, Inc.
Study Sponsor  ICMJE EirGenix, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account EirGenix, Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP