Overview

A Study of Cyclophosphamide/Methotrexate/5-Fluorouracil (CMF) With Pegfilgrastim in Subjects With Breast Cancer

Status:
Completed

Trial end date:
1969-12-31

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to assess the relative dose intensity (RDI) of intravenous (IV) CMF on a Day 1 and 8 schedule given every 28 days with pegfilgrastim support in subjects with stage I-III breast cancer.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Amgen

Treatments:

Cyclophosphamide
Fluorouracil
Methotrexate

Criteria

Inclusion Criteria: - Histologically confirmed breast cancer Stage I, II or III - Candidate
for IV CMF chemotherapy (every 4 weeks) for a total of 6 cycles - Chemotherapy naïve (prior
treatment with hormone therapy or with anti-HER2 monoclonal antibody therapy is permitted
as long as treatment has been stopped prior to enrollment into the study) - Absolute
neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L - Platelet count greater than
or equal to 100 x 10^9/L - Eastern Cooperative Oncology Group (ECOG) performance status of
0-2 - Written informed consent before any study specific procedure Exclusion Criteria: -
AST and/or ALT greater than 1.5 x upper limit of normal (ULN) concomitant with alkaline
phosphatase greater than 2.5 x ULN according to institutional standard - Bilirubin greater
than 2 x ULN according to institutional standard - Inadequate renal function (creatinine
greater than 1.5 x ULN according to institutional standard) - Any premalignant myeloid
condition or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes,
acute or chronic myelogenous leukaemias) - History of prior malignancy other than breast
cancer with the exception of curatively treated basal cell or squamous cell carcinoma of
the skin, in situ cervical carcinoma, or other surgically cured malignancy - Prior
radiotherapy - Scheduled concomitant radiotherapy (e.g., radiotherapy administration while
on study) - Documented active infection at the time of enrolment requiring use of systemic
anti- infectives - Documented positive test for human immunodeficiency virus (HIV)
infection - Known hypersensitivity to E coli derived products [e.g., Filgrastim
(Neupogen®), pegfilgrastim (Neulasta®), HUMULIN® Insulin, L-Asparaginase, HUMATROPE® Growth
Hormone, INTRON A®] - Subject is currently enrolled in or 30 days have not passed since
completing other investigational device or drug trial(s) or is receiving other
investigational agent(s) other than placebo (confirmation of prior treatment must be
documented) - Pregnant or breast-feeding (for subjects of child bearing potential) - Not
using adequate contraception (for subjects of child bearing potential) - Previous
participation in this study - Inability or unwillingness to comply with the protocol
procedures