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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Herceptin; Drug: EG12014

• Registration Number: NCT03433313
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-14
• Study Start: 2018-10-16
• Primary Completion: 2022-01-20
• Study Completion: 2022-01-20
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 807

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Herceptin	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.
EG12014	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.

Primary Outcome Measures

Name	Time	Method
Determination of pathologic complete response (pCR) at time of surgery	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

Secondary Outcome Measures

Name	Time	Method
Incidence of AEs	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
Measure serum trastuzumab concentration	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
pCR at the time of surgery	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
Overall survival (OS) up to End of Study (EOS)	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
Evaluation of Immunogenicity of EG12014 and Herceptin	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)
Event-free survival (EFS) up to end of study (EOS)	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	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

Trial Locations

Locations (89)

Detroit Clinical Research Center; 🇺🇸 Farmington Hills, Michigan, United States

Aultman Hospital, Cancer Center; 🇺🇸 Canton, Ohio, United States

Brest Regional Oncology Center; 🇧🇾 Brest, Belarus

Gomel Regional Clinical Oncology Center; 🇧🇾 Gomel, Belarus

N.N. Aleksandrov Republican Research Oncology and Medical Radiology Center; 🇧🇾 Lesnoy, Belarus

Minsk City Clinical Oncology Center; 🇧🇾 Minsk, Belarus

Mogilev Regional Oncology Center; 🇧🇾 Mogilev, Belarus

Vitebsk Regional Clinical Oncology Center; 🇧🇾 Vitebsk, Belarus

Medical Research Limited Society; 🇨🇱 Temuco, Chile

Oncocentro Apys; 🇨🇱 Viña Del Mar, Chile

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