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A Single-arm Study Evaluating the Relative Dose Intensity of IV CMF Given on Day 1 and Day 8 With Pegfilgrastim Support in Subjects With Stage I-III Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

A Single-arm Study Evaluating the Relative Dose Intensity of IV CMF Given on Day 1 and Day 8 With Pegfilgrastim Support in Subjects With Stage I-III Breast Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

To assess the relative dose intensity (RDI) of IV CMF Day 1 and 8 schedule given every 28 days with pegfilgrastim support in subjects with Stage I-III breast cancer.

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Spain: Spanish Agency of Medicines

Study ID:

20030156

NCT ID:

NCT00124111

Start Date:

Completion Date:

Related Keywords:

  • Breast Cancer
  • clinical trial
  • pegfilgrastim
  • haematopoietic growth factor
  • neutropenia
  • CMF
  • Cancer
  • Breast Neoplasms

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