A Phase II Trial of Sequential Epirubicin/Vinorelbine in Patients With Advanced Breast Cancer
- Assess the efficacy of sequential use of epirubicin hydrochloride followed by
vinorelbine ditartrate in patients with stage IIB, IIIA, IIIB, or IV breast cancer.
- Measure the biological response to this regimen in sequential tumor biopsies and
peripheral mononuclear cells from these patients.
- Correlate tumor response with changes in the gene expression of microtubule-associated
OUTLINE: Patients receive epirubicin hydrochloride IV on day 1 and vinorelbine ditartrate IV
over 6-10 minutes on days 3 and 17. Patients also receive filgrastim (G-CSF) subcutaneously
on days 4-14 or pegfilgrastim IV on day 4.
For patients with stage IIB (T3, N0), IIIA, or IIIB disease, treatment repeats every 21 days
for up to 5 courses in the absence of disease progression or unacceptable toxicity. For
patients with stage IV disease, treatment repeats every 21 days in the absence of disease
progression or unacceptable toxicity.
Blood samples are collected at baseline and after course 1 for research studies. Patients
with accessible tumor for biopsy undergo sequential biopsies and core needle biopsies at
baseline and after course 1. Tumor tissue samples are used for determination of p53 status
by western blot analysis, immunohistochemistry, and DNA sequencing. Microtubule-associated
protein 4, p53, and p21/WAF1 expression is analyzed by western blotting.
After completion of study treatment, patients are followed for 1 month.
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Deborah L. Toppmeyer, MD
Cancer Institute of New Jersey
United States: Food and Drug Administration
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|