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Epirubicin and Vinorelbine in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer

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ClinicalTrials.gov Identifier: NCT00176488
Recruitment Status : Terminated (Competing studies)
First Posted : September 15, 2005
Results First Posted : November 25, 2013
Last Update Posted : March 23, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: epirubicin Drug: vinorelbine Phase 2

Detailed Description:


  • 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Sequential Epirubicin/Vinorelbine in Patients With Advanced Breast Cancer
Study Start Date : June 2003
Primary Completion Date : October 2009
Study Completion Date : October 2009

Arms and Interventions

Arm Intervention/treatment
Experimental: Sequential epirubicin/vinorelbine
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.
Drug: epirubicin
Epirubicin (100 mg/m2) will be given on Day 1
Other Name: epirubicin hydrochloride
Drug: vinorelbine
Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.
Other Name: vinorelbine ditartrate

Outcome Measures

Primary Outcome Measures :
  1. Efficacy of the Sequential Use of a DNA Damaging Drug (Epirubicin) Followed by a Vinca Alkaloid (Vinorelbine) in the Treatment of Breast Cancer. [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Biological Response to Epirubicin and Vinorelbine Administered in Patients With Breast Cancer in Sequential Tumor Biopsies and Peripheral Blood Mononuclear Cells. [ Time Frame: 10 years ]
  2. Correlate Tumor Response With Changes in the Gene Expression of Microtubule Associated Protein 4 (MAP4). [ Time Frame: 10 years ]

Eligibility Criteria

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Ages Eligible for Study:   21 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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 allowed
  • No concurrent radiotherapy except for brain metastases
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00176488

United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
National Cancer Institute (NCI)
Principal Investigator: Deborah L. Toppmeyer, MD Rutgers Cancer Institute of New Jersey
More Information

Responsible Party: University of Medicine and Dentistry of New Jersey
ClinicalTrials.gov Identifier: NCT00176488     History of Changes
Other Study ID Numbers: CDR0000539565
P30CA072720 ( U.S. NIH Grant/Contract )
CINJ 040302 ( Other Identifier: Cancer Institute of New Jersey )
First Posted: September 15, 2005    Key Record Dates
Results First Posted: November 25, 2013
Last Update Posted: March 23, 2017
Last Verified: February 2017

Keywords provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):
recurrent breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IV breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors