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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 : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
EirGenix, Inc.

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: EG12014 Drug: Herceptin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : August 5, 2020
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.
Drug: EG12014
EG12014 6mg/kg is ongoing to be administered after 8mg/kg loading dose.

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.
Drug: Herceptin
Herceptin 6mg/kg is ongoing to be administered after 8mg/kg loading dose.




Primary Outcome Measures :
  1. Determination of pathologic complete response (pCR) at time of surgery [ Time Frame: At the time of surgery (12 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


Secondary Outcome Measures :
  1. pCR at the time of surgery [ Time Frame: At the time of surgery (12 weeks after completion of neoadjuvant chemotherapy) ]
    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

  2. 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 ]
    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

  3. Overall response (OR) prior to surgery [ Time Frame: At screening and prior to surgery (12 weeks after completion of neoadjuvant chemotherapy) ]
    Objective response is defined as partial response (PR) or complete response (CR) according to RECIST v1.1

  4. Overall survival (OS) up to End of Study (EOS) [ Time Frame: Randomization to end of study (up to approximately 72 weeks) or death ]
    OS up to EOS is defined as time from the date of initial randomization to the date of death

  5. Incidence of AEs [ Time Frame: From time of informed consent to end of study (up to approximately 72 weeks) or death ]
    Incidence of AEs (including severity, seriousness, and relationship to study drug) and laboratory abnormalities

  6. Evaluation of Immunogenicity of EG12014 and Herceptin [ Time Frame: End of treatment (up to ~55 weeks) ]
    Titer of anti-drug antibodies (ADA)

  7. 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) ]
    Measure serum trastuzumab concentration for EG12014 and Herceptin arms



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433313


Contacts
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Contact: Udo Kiessling, MD PhD +49 176 61901762 udo.kiessling@eirgenix.com

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Sponsors and Collaborators
EirGenix, Inc.

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Responsible Party: EirGenix, Inc.
ClinicalTrials.gov Identifier: NCT03433313     History of Changes
Other Study ID Numbers: EGC002
2017-003973-33 ( EudraCT Number )
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological