This is a clinical trial to compare the safety and effectiveness of Eirgenix trastuzumab with Herceptin as Neoadjuvant treatment in HER2 positive Early Stage Breast Cancer

Phase 3

• Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

• Registration Number: CTRI/2018/09/015794
• Lead Sponsor: Eirgenix Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients will be entered into this study only if they meet all of the following 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] Stage II, IIIa [43]).

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, defined as 3+ score by IHC or fluorescence positive by FISH.

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 mg/dL

10. International normalized ratio <=1.5Ã?ULN (2 to 3Ã?ULN if on anticoagulants) or

prothrombin time <=1.5Ã?ULN; activated partial thromboplastin time <=1.5Ã?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.

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 6 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.

4.2 Inclusion Criterion after Surgery (Adjuvant Part of the Study)

After completion of the neoadjuvant part of the study and surgery, patients will be

eligible for double-blind adjuvant therapy with EG12014 or Herceptin if they meet the

following criterion:

1. No sequelae have occurred after neoadjuvant therapy, in particular regarding cardiac

function. No separate informed consent is required.

Exclusion Criteria

Patients will be entered into this study only if they meet none of the following 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to demonstrate therapeutic <br/ ><br>equivalence of EG12014 and Herceptin, both given in combination <br/ ><br>with paclitaxel for 12 weeks (4 cycles) as part of neoadjuvant <br/ ><br>therapy in patients with human epidermal growth factor receptor 2 <br/ ><br>(HER2)-positive early breast cancer (EBC), in terms of efficacy <br/ ><br>determined by pathological complete response (pCR) (ypT0/is ypN0) <br/ ><br>at the time of surgery, assessed by central laboratory.Timepoint: Tumor response will be evaluated after completion of the neoadjuvant treatment and prior to surgery by clinical examination, mammography, and /or ultrasound and CT/MRI. Resected specimens of breast tissue and axillary lymph nodes will be evaluated for <br/ ><br>pathological response by a central laboratory, and used for the assessment of the primary <br/ ><br>endpoint.