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A Phase II Trial of Sequential Epirubicin/Vinorelbine in Patients With Advanced Breast Cancer

Phase 2
21 Years
Not Enrolling
Breast Cancer

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Trial Information

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
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.

Inclusion Criteria


- Histologically confirmed stage IIB (T3, N0), IIIA, IIIB, or IV breast carcinoma

- Original tumor must be available for analysis of p53 status

- Measurable disease, defined as any lesion that can be accurately measured in ≥ 1
dimension with longest diameter ≥ 20 mm using conventional techniques OR ≥ 10 mm with
spiral CT scan

- Stage IIIB disease will be assessed by clinical exam (monitoring skin changes as
well as tumor size)

- No visceral crisis (lymphangitic pulmonary spread, or liver or marrow replacement
sufficient to cause significant organ dysfunction)

- No untreated CNS metastases

- Hormone receptor status not specified


- Menopausal status not specified

- ECOG performance status 0-2

- Life expectancy ≥ 8 weeks

- Absolute neutrophil count ≥ 1,000/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 10 g/dL

- Bilirubin normal

- AST ≤ 3 times normal (≤ 5 times normal if liver metastases are present)

- Creatinine ≤ 1.5 mg/dL

- Ejection fraction ≥ lower limit of normal by MUGA scan or ECG

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective nonhormonal contraception

- No other malignancy except for adequately treated basal cell or squamous cell skin
cancer or in situ cervical cancer

- No pre-existing disease (i.e., cardiac, pulmonary, neurologic, or other disease) that
the investigator judges to be clinically significant

- No active infectious process, severe malnutrition, or intractable emesis


- Recovered from all prior therapy

- At least 3 weeks since prior radiotherapy

- At least 3 weeks since prior chemotherapy

- Maximum prior doxorubicin hydrochloride dose must be ≤ 300 mg/m² OR equivalent
anthracycline (epirubicin hydrochloride) dose must be ≤ 540 mg/m² OR calculated
total anthracycline dose must be ≤ 540 mg/m² (determined as 1.8 times total
doxorubicin hydrochloride dose plus epirubicin hydrochloride dose)

- No prior chemotherapy for metastatic disease

- Prior adjuvant chemotherapy, radiotherapy, and/or hormonal therapy for breast cancer

- No concurrent radiotherapy except for brain metastases

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

10 years

Safety Issue:


Principal Investigator

Deborah L. Toppmeyer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey


United States: Food and Drug Administration

Study ID:




Start Date:

June 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IV breast cancer
  • male breast cancer
  • Breast Neoplasms



Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903