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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
epirubicin
vinorelbine
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring recurrent breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IV breast cancer, male breast cancer

Eligibility Criteria

21 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: 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 PRIOR CONCURRENT THERAPY: 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

Sites / Locations

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sequential epirubicin/vinorelbine

Arm Description

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.

Outcomes

Primary Outcome Measures

Efficacy of the Sequential Use of a DNA Damaging Drug (Epirubicin) Followed by a Vinca Alkaloid (Vinorelbine) in the Treatment of Breast Cancer.

Secondary Outcome Measures

Biological Response to Epirubicin and Vinorelbine Administered in Patients With Breast Cancer in Sequential Tumor Biopsies and Peripheral Blood Mononuclear Cells.
Correlate Tumor Response With Changes in the Gene Expression of Microtubule Associated Protein 4 (MAP4).

Full Information

First Posted
September 12, 2005
Last Updated
February 20, 2017
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00176488
Brief Title
Epirubicin and Vinorelbine in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer
Official Title
A Phase II Trial of Sequential Epirubicin/Vinorelbine in Patients With Advanced Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Competing studies
Study Start Date
June 2003 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequential epirubicin/vinorelbine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
epirubicin
Other Intervention Name(s)
epirubicin hydrochloride
Intervention Description
Epirubicin (100 mg/m2) will be given on Day 1
Intervention Type
Drug
Intervention Name(s)
vinorelbine
Other Intervention Name(s)
vinorelbine ditartrate
Intervention Description
Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Correlate Tumor Response With Changes in the Gene Expression of Microtubule Associated Protein 4 (MAP4).
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: 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 PRIOR CONCURRENT THERAPY: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah L. Toppmeyer, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States

12. IPD Sharing Statement

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

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