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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00124111
• Other study ID #: 20030156
• Status: Completed
• Phase: Phase 2
• First received: July 25, 2005
• Last updated: February 25, 2010

Study information

• Verified date: February 2010
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• pegfilgrastim

• cyclophosphamide

• methotrexate

• 5-fluorouracil

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

Mattioli R, Gridelli C, Castellanos J, Duque A, Falcone A, Mansutti M, Bacon P, Lawrinson S, Skacel T, Casas A. Use of pegfilgrastim support on day 9 to maintain relative dose intensity of chemotherapy in breast cancer patients receiving a day 1 and 8 CMF — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	Incidence of febrile neutropenic events over all cycles
Secondary	Incidence of dose delays and dose reductions of planned chemotherapy due to neutropenic events
Secondary	Safety profile over all cycles

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling