A study comparing the efficacy and safety of LA-EP2006 and Neulasta in breast cancer patients being treated with types of chemotherapy which decrease white blood cells.

• Conditions: Breast Cancer; MedDRA version: 14.1Level: LLTClassification code 10006203Term: Breast cancer stage unspecifiedSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-004532-58-BG
• Lead Sponsor: Sandoz GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-22
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 302

Inclusion Criteria

The patients must fulfill all of the following criteria to be eligible for admission to the study:
•Written informed consent before any assessment is performed
•Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant TAC chemotherapy
•Women = 18 years of age
•Estimated life expectancy of more than six months
•Eastern cooperative oncology group (ECOG) performance status = 2
•Adequate bone marrow function on Cycle 1 Day 1 prior to chemotherapy administration:
•ANC = 1.5 x 10 9/L
•Platelet count = 100 x 10 9/L
•Hemoglobin = 10 g/dL
•Total bilirubin not higher than the upper limit of normal (ULN), unless the patient has Gilbert`s syndrome
•Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) level = 2 x ULN
•Liver-derived alkaline phosphatase level = 3 x ULN
•Creatinine = 1.5 x ULN
•For all women of childbearing potential: negative serum pregnancy test within seven days prior to randomization, and using a highly effective method of birth control
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 302
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

The patients meeting any of the following exclusion criteria will not be enrolled in the study:
1. History of chronic myeloid leukemia or myelodysplastic syndrome
2. History or presence of sickle cell disease
3. Previous or concurrent malignancy except non-invasive non-melanomatous skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least ten years prior to study entry
4. Any serious illness or medical condition that may interfere with safety, compliance, response to the products under investigation or chemotherapy and their evaluation such as:
• Active uncontrolled infection
• Clinically significant impairment of left ventricular ejection fraction
(LVEF measured within three month before study entry by
echocardiography or multiple-gated acquisition scan (MUGA) must be above the lower limit of normal for the respective center)
• Severe valvular heart disease, myocardial infarction, unstable angina pectoris, uncontrolled hypertension or uncontrolled arrhythmias within six months from study entry
• Significant neurologic or psychiatric disorders including psychotic
disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
5. Concurrent or prior radiotherapy within four weeks of randomization
6. Concurrent or prior chemotherapy for breast cancer
7. Concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies and/or biological therapy
8. Concurrent prophylactic antibiotics
9. Prior bone marrow or stem cell transplant
10. Previous therapy with any rhG-CSF product
11. Known hypersensitivity to E. coli proteins or any of the excipients used in the IMPs
12. Patient known to have HIV, Hepatitis B, Hepatitis C infection or who have positive serology for HIV, Hepatitis B or Hepatitis C at screening
13. Known active drug addiction, including alcoholism
14. Participation in any other clinical study using an IMP or device within three months before the screening visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified