PIVOTAL STUDY IN PATIENTS WITH BREAST CANCER TO INVESTIGATE THE EFFICACY AND SAFETY OF LA-EP2006 and NEULASTA ®

Not Applicable

• Registration Number: PER-119-11
• Lead Sponsor: Sandoz GmbH,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-09
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Female
• Target Recruitment: 0

Inclusion Criteria

1. WRITTEN INFORMED CONSENT BEFORE ANY EVALUATION
2. BREAST CANCER PATIENTS HISTOLOGICALLY DOCUMENTED, WHO ARE ABLE TO RECEIVE NEOADJUVANT OR ADJUVANT CHEMOTHERAPY WITH IAE
3. ≥ 18 YEARS OLD WOMEN
4. ESTIMATED LIFE EXPECTANCE OVER SIX MONTHS
5. FUNCTIONAL STATUS OF EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) ≤ 2
6. APPROPRIATE PERFOMANCE OF BONE MARROW IN DAY 1 OF CYCLE 1, BEFORE ADMINISTERING CHEMOTHERAPY:
• ANC ≥ 1.5 × 10⁹/l
• PLATELET COUNT ≥ 100 × 10⁹/l
• HEMOGLOBIN ≥ 1O g/dl
7. TOTAL BILIRUBIN WHICH IS NOT ABOVE THE UPPER LIMIT OF NORMAL (LSN), UNLESS THE PATIENT HAVE GILBERT SYNDROME
8. LEVEL ASPARTATE AMINOTRANSFERASE (AST) AND ALANINE AMINOTRANSFERASE (ALT) ≤ X ULN
9. LIVER ALKALINE PHOSPHATASE LEVEL ≤ 3 x ULN
10.CREATININA ≤ 1.5 X ULN
11.SERUM PREGNANCY TEST NEGATIVE SEVEN DAYS PRIOR TO THE RANDOMISATION IN ALL WOMEN IN REPRODUCTIVE AGE

Exclusion Criteria

1. HISTORY OF CHRONIC MYELOID LEUKEMIA OR MYELODYSPLASTIC SYNDROME
2. HISTORY OR PRESENCE OF SICKLE CELL DISEASE
3. PRIOR OR CONCURRENT MALIGNANCY EXCEPT FOR NON-INVASIVE SKIN CANCER AND NON-MELANOMA, CARCINOMA IN SITU OF UTERINE CERVIX OR OTHER SOLID TUMOR TREATED WITH HEALING THERAPIES AND NO SIGNS OF RELAPSE FOR AT LEAST TEN YEARS BEFORE GOING INTO THE STUDY.
4. ANY SERIOUS ILLNESS OR SEVERE MEDICAL DISEASES THAT MAY INTERFERE WITH THE SAFETY, COMPLIANCE, THE ANSWER TO THE PRODUCTS ON RESEARCH AND EVALUATION, FOR EXAMPLE:
• ACTIVE INFECTION WITHOUT CONTROL
• CLINICALLY SIGNIFICANT ALTERATION OF LEFT VENTRICULAR EJECTION FRACTION (LVEF MUST BE DETERMINED BY ECHOCARDIOGRAPHY THAT MUST BE ABOVE NORMAL LOWER LIMIT OF THE RESPECTIVE CENTER) SEVERE DISEASE OF HEART VALVES, HEART ATTACK, Unstable Angina, UNCONTROLLED HYPERTENSION OR UNCONTROLLED ARRHYTHMIAS IN THE SIX MONTHS PRIOR TO ENTER THE STUDY
• HISTORY OF SIGNIFICATIVE NEUROLOGICAL OR PSYCHIATRIC DISORDERS, INCLUDING PSYCHOTIC DISORDERS, DEMENTIA OR CONVULSIVE SEIZURES THAT AVOID TO UNDERSTAND OR GIVE INFORMED CONSENT.

Study & Design

• Study Type: Interventional
• Study Design: Not specified