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Study Complete
Sponsor ID
20020106

Treatment for Elderly Patients with High Risk Breast Cancer

Sponsor ID
20020106
Clinicaltrials.gov ID
NCT00117910
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

This open-label, multicenter study explored primary and secondary prophylaxis treatment with a single, fixed-dose, subcutaneous (SC) injection of pegfilgrastim in elderly subjects with high-risk breast cancer receiving myelosuppressive chemotherapy. The primary objective was to provide preliminary information on the incidence of protocol defined neutropenic events in chemotherapy cycle 1.

Additional Study Details

Phase
Phase 3
Product
pegfilgrastim
Type
Interventional
Masking
None (Open Label)
Enrollment
N/A
Additional Study Details

Protocol Summary

Primary Outcome Measures
Not Available
Secondary Outcome Measures
Not Available

Locations

No locations found.
Study Info
Age
65+ years
Condition
  • Breast Cancer
    • Sex
    Assigned Female at Birth
    Trial Dates
    Oct 2002 - N/A
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - High-risk, stage II-III breast cancer suitable for treatment with up to 6 cycles of FEC-100 - Chemotherapy - Histologically proven greater than or equal to 1 axillary nodes positive - Oestrogen receptor negative or positive - Chemotherapy naïve - VES 13 (Vulnerable Elders Survey) score less than or equal to 3 - ECOG performance status less than or equal to 2 - ANC greater than or equal to 1.5 x 10^9/L - Platelets greater than or equal to 100 x 10^9/L - Adequate renal function (serum creatinine less than 1.5 x upper limit of normal (ULN)) - Before any study specific procedure the subject must give written informed consent for participation in the study
    Exclusion Criteria:
    - Total serum bilirubin greater than ULN according to institutional standard - Clinically significant cardiac disease that would preclude the use of epirubicin (e.g., LVEF (left ventricular ejection fraction)) less than 45% at rest by MUGA or echocardiogram - Prior bone marrow or stem cell transplantation - Any premalignant myeloid condition or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukaemia) - History of prior malignancy other than breast cancer with the exception of curatively treated basal cell carcinoma, in situ cervical carcinoma or surgically cured malignancies - Prior radiation therapy - Active infection or administration of systemic antibiotics or anti-infectives within 72 hours before start of chemotherapy - Known hypersensitivity to E coli-derived products (e.g., Filgrastim, HUMULIN®, Insulin, L-Asparaginase, HUMATROPE®, Growth Hormone, INTRON A®) - Previous exposure to pegfilgrastim or previous entry into this study - Known HIV infection - Inability to understand the nature of the study and provide written informed consent - Subject currently enrolled in another investigational device or drug trial(s) or has received other investigational agent(s), with the exception of placebo-treated subjects, within the last 30 days - Concerns for subject's compliance with the protocol procedures