Clinical Trials /

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:

Active, not 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

        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 (American Joint Committee on
             Cancer [AJCC, vs. 8.0] Stage II, IIIa).

          4. Operable breast cancer, planned surgical resection of breast tumor (mastectomy or
             lumpectomy) and sentinel or axillary lymph nodes.

          5. Unilateral, measurable tumor of the breast >2 cm in diameter.

          6. HER2 positive tumor, defined as 3+ score by IHC or fluorescence positive by FISH, as
             confirmed by central laboratory.

          7. Known estrogen receptor (ER) and progesterone receptor (PrR) status at study entry.

          8. Adequate bone marrow function, defined as granulocyte count of ≥1.500/µL, and platelet
             count of ≥100.000/µL.

          9. Adequate hepatic and renal function, defined as:

             bilirubin within normal range

             alanine aminotransferase (ALT) ≤2 x upper limit of normal (ULN)

             aspartate aminotransferase (AST) ≤2 x ULN

             gamma glutamyl transferase (GGT) ≤3 x ULN

             serum creatinine <1.5 ULN

         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 ≥10 g/dL.

         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.

        Females with childbearing potential must provide a negative serum pregnancy test at
        Screening and must be using adequate birth control. Adequate birth control is defined as
        agreement to consistently practice an effective and accepted method of contraception
        throughout the duration of the study and for 7 months after study drug treatment. These
        methods include hormonal contraceptives, intrauterine device, or double barrier
        contraception (i.e., condom + diaphragm) or a male partner with documented vasectomy.

        Non-childbearing potential is defined as post-menopausal for at least 1 year or surgical
        sterilization or hysterectomy at least 3 months before study start.

        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 malignancy, other than basal cell
             carcinoma of the skin. Previous treatment for carcinoma in situ of the cervix is
             allowed.

          5. Previous treatment with Herceptin.

          6. Angina pectoris or arrhythmia requiring medication; poorly controlled hypertension;
             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; LVEF of <55%.

          7. 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.

          8. Positive diagnostic test for hepatitis B virus (HBV), hepatitis C virus (HCV), or
             human immunodeficiency virus (HIV).

          9. History of hypersensitivity to drugs with similar chemical structures to trastuzumab.

         10. History of, or known current problems with, drug or alcohol abuse.

         11. 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 (3-6 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 (3-6 weeks after completion of neoadjuvant chemotherapy)
Safety Issue:
Description: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
Measure:pCR at the time of surgery
Time Frame:At the time of surgery (3-6 weeks after completion of neoadjuvant chemotherapy)
Safety Issue:
Description:pCR is defined as the absence of invasive cancer in breast tissue only (ypT0/is) 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 24 months 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 (3-6 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 24 months 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 25 months 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:Prior to 1st infusion of study drug, during neoadjuvant treatment, after the last dose of neoadjuvant treatment, during adjuvant treatment, and End of Treatment
Safety Issue:
Description:Titer of anti-drug antibodies (ADA)
Measure: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
Safety Issue:
Description:Measure serum trastuzumab concentration for EG12014 and Herceptin arms

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:EirGenix, Inc.

Last Updated

April 6, 2020