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

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
University of Medicine and Dentistry of New Jersey
Study ID
NCT00176488
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • epirubicin — DRUG
    Epirubicin (100 mg/m2) will be given on Day 1
  • vinorelbine — DRUG
    Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.

Study Details

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.

Key Dates

Start date
Jun 30, 2003
Status verified
Feb 2017
Primary completion
Oct 31, 2009
Completion
Oct 31, 2009

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew BrunswickNew Jersey08903-

Find similar trials in New Brunswick, NJ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School· New Brunswick, NJ

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