Conditions: Breast Cancer
Keywords: recurrent breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IV breast cancer male breast cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 31
Healthy volunteers: no

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as epirubicin and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving epirubicin together with vinorelbine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving epirubicin together with vinorelbine works in treating patients with stage II, stage III, or stage IV breast cancer.

Detailed description:
OBJECTIVES:

* 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 protein 4.

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.

Arms:
arm 1: For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.

Interventions: intervention 1: epirubicin intervention 2: vinorelbine
Intervention descriptions: intervention 1: Epirubicin (100 mg/m2) will be given on Day 1 intervention 2: Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.

Protocol document: