Status:
COMPLETED
Treatment for Elderly Patients With High Risk Breast Cancer
Lead Sponsor:
Amgen
Conditions:
Breast Cancer
Eligibility:
FEMALE
65+ years
Phase:
PHASE3
Brief Summary
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 breas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00117910
Start Date
October 1 2002
End Date
May 1 2004
Last Update
May 16 2008
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.