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An Open Label, Randomised, Multicentre Study of Pegfilgrastim in Primary Versus Secondary Prophylaxis of Neutropenia as an Adjunct to Chemotherapy in Elderly Subjects With High Risk Breast Cancer.


Phase 3
65 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

An Open Label, Randomised, Multicentre Study of Pegfilgrastim in Primary Versus Secondary Prophylaxis of Neutropenia as an Adjunct to Chemotherapy in Elderly Subjects With High Risk Breast Cancer.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Provide preliminary information on the incidence of protocol defined neutropenic events in chemotherapy cycle 1.

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

20020106

NCT ID:

NCT00117910

Start Date:

October 2002

Completion Date:

May 2004

Related Keywords:

  • Breast Cancer
  • Aged, Granulocyte Colony-Stimulating Factor
  • Combined Modality Therapy, Neutropenia
  • pegfilgrastim, Neulasta®
  • FEC-100, Antineoplastic Agents
  • Breast Cancer, Female
  • Breast Neoplasms

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