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Clinical Trials/PER-119-11
PER-119-11
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PIVOTAL STUDY IN PATIENTS WITH BREAST CANCER TO INVESTIGATE THE EFFICACY AND SAFETY OF LA-EP2006 and NEULASTA ®

Sandoz GmbH,0 sites0 target enrollmentMay 9, 2012
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Sandoz GmbH,
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 9, 2012
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Sandoz GmbH,

Eligibility Criteria

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

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.

Outcomes

Primary Outcomes

Not specified

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