A study comparing the efficacy and safety of EP2006 and Neupogen® inbreast cancer patients being treated with types of chemotherapy whichdecrease white blood cells
- Conditions
- Breast cancerMedDRA version: 14.1Level: LLTClassification code 10006203Term: Breast cancer stage unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-024481-22-CZ
- Lead Sponsor
- Sandoz GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 192
1. Written informed consent before any assessment is performed
2. Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant TAC chemotherapy
3. Women = 18 years of age
4. Estimated life expectancy of more than six months
5. Eastern Cooperative Oncology Group (ECOG) performance status = 2
6. Adequate bone marrow function on Cycle 1 Day 1, prior to chemotherapy administration:
• ANC = 1.5 x 109/L
• Platelet count = 100 x 109/L
• Hemoglobin = 10 g/dL
7. Total bilirubin within normal limits, unless the patient has Gilbert’s syndrome
8. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) level = 2 x upper limit of normal (ULN)
9. Liver-derived alkaline phosphatase level = 3 x ULN
10. Creatinine = 1.5 x ULN
11. 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 163
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 29
1. History of myelogenous leukemia or myelodysplastic syndrome
2. History or presence of sickle cell disease
3. Previous or concurrent malignancy except non-invasive non-melanoma 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 or who have a positive serology for HIV, Hepatitis B or Hepatitis C at screening
13. Known control 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method