EUCTR2012-002039-28-ES
Active, not recruiting
Phase 1
Pivotal study in breast cancer patients investigating efficacy and safety of LA-EP2006 and Neulasta®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Sandoz GmbH
- Enrollment
- 308
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 not higher than the upper limit of normal (ULN), unless the patient has Gilbert\`s syndrome
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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