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Vinorelbine in Treating Older Women With Stage IV Breast Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology Identifier:
First received: August 10, 2001
Last updated: July 1, 2016
Last verified: July 2016

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating older women who have stage IV breast cancer.

Condition Intervention Phase
Breast Cancer
Drug: vinorelbine tartrate
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Oral Vinorelbine for the Treatment of Metastatic Breast Cancer in Patients >65 Years of Age: A Trial of Efficacy, Toxicity, and Patients' Perceived Preference for Oral Therapy

Resource links provided by NLM:

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • objective response rate [ Time Frame: Up to 5 years ]

Secondary Outcome Measures:
  • time to progression [ Time Frame: Up to 5 years ]
  • quality of life [ Time Frame: Up to 5 years ]

Enrollment: 25
Study Start Date: November 2001
Study Completion Date: August 2007
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vinorelbine

Patients receive oral vinorelbine once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then after completion of the second course.

Patients are followed every 3 months for 5 years.

Drug: vinorelbine tartrate

Detailed Description:


  • Determine the objective response rate in elderly women with stage IV breast cancer treated with oral vinorelbine.
  • Determine the toxicity profile of this drug in these patients.
  • Determine the time to progression in patients treated with this drug.
  • Determine the quality of life of patients treated with this drug.
  • Assess individual variation in responses (toxicity and/or activity), pharmacokinetic parameters, and/or biologic correlates due to genetic differences in enzymes involved in the transport, metabolism, and/or mechanism of action of this drug in these patients.

OUTLINE: Patients receive oral vinorelbine once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then after completion of the second course.

Patients are followed every 3 months for 5 years.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed stage IV breast cancer
  • Eligible to receive first- or second-line chemotherapy
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm in longest diameter
    • Must be completely outside prior irradiation port unless there is proof of progressive disease after completion of prior radiotherapy
  • No untreated brain metastases

    • Current metastatic CNS disease allowed only if previously treated and clinically stable at study entry
  • No meningeal carcinomatosis
  • Hormone receptor status:

    • Not specified



  • 65 and over


  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR
  • Direct bilirubin normal if total bilirubin elevated or less than 2.5 times ULN because of Gilbert's syndrome


  • Creatinine no greater than 2 times ULN


  • No grade 2 or greater peripheral neuropathy
  • No other significant medical condition that would preclude study
  • No active infection within the past 2 weeks
  • No dysphagia or inability to swallow intact capsules


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • No more than 1 prior chemotherapy regimen for metastatic disease
  • No prior vinca alkaloids
  • At least 4 weeks since other prior chemotherapy and recovered

Endocrine therapy:

  • Prior hormonal therapy allowed
  • No concurrent hormonal therapy


  • See Disease Characteristics
  • No prior radiotherapy to 25% or more of bone marrow
  • At least 3 weeks since prior radiotherapy and recovered


  • At least 3 weeks since prior major surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00022152

United States, Arizona
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Illinois
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
Siouxland Hematology-Oncology
Sioux City, Iowa, United States, 51101-1733
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Michigan
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CentraCare Health Plaza
Saint Cloud, Minnesota, United States, 56303
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
United States, North Dakota
Medcenter One Health System
Bismarck, North Dakota, United States, 58501
Altru Health Systems
Grand Forks, North Dakota, United States, 58201
United States, Pennsylvania
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57104
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Edith A. Perez, MD Mayo Clinic
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00022152     History of Changes
Other Study ID Numbers: NCCTG-N003A
NCI-2012-02395 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000068790 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: August 10, 2001
Last Updated: July 1, 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
stage IV breast cancer
recurrent 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 processed this record on April 28, 2017