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

NCT03433313

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: EGC002
  • SECONDARY ID: 2017-003973-33
  • NCT ID: NCT03433313

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
EG12014EG12014
HerceptinHerceptin

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
EG12014ExperimentalEpirubicin 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.
  • EG12014
HerceptinActive ComparatorEpirubicin 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.
  • Herceptin

Eligibility Criteria

        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.
      
Maximum Eligible Age:65 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Determination of pathologic complete response (pCR) at time of surgery
Time Frame:At the time of surgery (12 weeks after completion of neoadjuvant chemotherapy)
Safety Issue:
Description: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

Secondary Outcome Measures

Measure:pCR at the time of surgery
Time Frame:At the time of surgery (12 weeks after completion of neoadjuvant chemotherapy)
Safety Issue:
Description:pCR is defined as the absence of residual invasive cancer and of DCIS (ypT0 ypN0) from breast tissue and sentinel/axillary lymph nodes, as assessed by central laboratory
Measure:Event-free survival (EFS) up to end of study (EOS)
Time Frame:Randomization to date of progression or end of study (up to approximately 72 weeks) or death
Safety Issue:
Description: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
Measure:Overall response (OR) prior to surgery
Time Frame:At screening and prior to surgery (12 weeks after completion of neoadjuvant chemotherapy)
Safety Issue:
Description:Objective response is defined as partial response (PR) or complete response (CR) according to RECIST v1.1
Measure:Overall survival (OS) up to End of Study (EOS)
Time Frame:Randomization to end of study (up to approximately 72 weeks) or death
Safety Issue:
Description:OS up to EOS is defined as time from the date of initial randomization to the date of death
Measure:Incidence of AEs
Time Frame:From time of informed consent to end of study (up to approximately 72 weeks) or death
Safety Issue:
Description:Incidence of AEs (including severity, seriousness, and relationship to study drug) and laboratory abnormalities
Measure:Evaluation of Immunogenicity of EG12014 and Herceptin
Time Frame:End of treatment (up to ~55 weeks)
Safety Issue:
Description:Titer of anti-drug antibodies (ADA)
Measure:Measure serum trastuzumab concentration
Time Frame:Before the first infusion of study drug, during neoadjuvant treatment (at ~6 weeks and ~12 weeks of treatment), during adjuvant treatment (every 4 cycles [3 weeks/cycle] for up to 12 months), and End of Treatment (EOT) (up to ~55 weeks)
Safety Issue:
Description:Measure serum trastuzumab concentration for EG12014 and Herceptin arms

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:EirGenix, Inc.

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