NCT00176488

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Jun 2003

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

November 25, 2013

Completed
Last Updated

March 23, 2017

Status Verified

February 1, 2017

Enrollment Period

6.3 years

First QC Date

September 12, 2005

Results QC Date

September 18, 2013

Last Update Submit

February 20, 2017

Conditions

Breast Cancer

Keywords

recurrent breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IV breast cancermale breast cancer

Outcome Measures

Primary Outcomes (1)

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

    10 years

Secondary Outcomes (2)

  • Biological Response to Epirubicin and Vinorelbine Administered in Patients With Breast Cancer in Sequential Tumor Biopsies and Peripheral Blood Mononuclear Cells.

    10 years

  • Correlate Tumor Response With Changes in the Gene Expression of Microtubule Associated Protein 4 (MAP4).

    10 years

Study Arms (1)

Sequential epirubicin/vinorelbine

EXPERIMENTAL

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: epirubicinDrug: vinorelbine

Interventions

epirubicinDRUG

Epirubicin (100 mg/m2) will be given on Day 1

Also known as: epirubicin hydrochloride
Sequential epirubicin/vinorelbine
vinorelbineDRUG

Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.

Also known as: vinorelbine ditartrate
Sequential epirubicin/vinorelbine

Eligibility Criteria

Age21 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

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

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsBreast Neoplasms, Male

Interventions

EpirubicinVinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Results Point of Contact

Title
Deborah Toppmeyer, MD
Organization
Cancer Institute of New Jersey
toppmede@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu
732-235-8675

Study Officials

  • Deborah L. Toppmeyer, MD

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

June 1, 2003

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

March 23, 2017

Results First Posted

November 25, 2013

Record last verified: 2017-02

Locations

US(1)