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Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00049660
Recruitment Status : Terminated (low accrual)
First Posted : January 27, 2003
Last Update Posted : July 18, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if capecitabine is more effective than vinorelbine in treating metastatic breast cancer.

PURPOSE: Randomized phase II/III trial to compare the effectiveness of capecitabine with that of vinorelbine in treating women who have metastatic breast cancer that has been previously treated with chemotherapy.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: capecitabine Drug: vinorelbine tartrate Phase 2 Phase 3

Detailed Description:


  • Compare the response rate in women with previously treated metastatic breast cancer treated with capecitabine vs vinorelbine.
  • Compare the duration of response in patients treated with these drugs.

Phase III Study:

  • Compare overall and progression-free survival in patients treated with these drugs.
  • Compare time to treatment failure in patients treated with these drugs.
  • Compare overall safety of these drugs in these patients.
  • Compare quality of life and clinical benefit response in patients treated with these drugs.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and taxane resistance (refractory vs resistant vs sensitive).

  • Phase II: Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive vinorelbine IV on days 1 and 8. Courses repeat every 21 days.
    • Arm II: Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days.

In both arms, treatment continues in the absence of progression or unacceptable toxicity.

If sufficient response rate is determined in phase II, the phase III study is initiated.

  • Phase III: Patients are randomized and receive treatment as in phase II. Quality of life is assessed prior to randomization, at weeks 3, 6, 9, 18, 24, and 30, and then every 12 weeks until disease progression.

Clinical benefit response is assessed daily while patient is on study.

Patients are followed every 6 weeks until disease progression and then every 12 weeks thereafter.

PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for phase II of this study and a total of 406-452 patients (203-226 per treatment arm) will be accrued for phase III of this study within 18.5 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Phase II-III Trial Evaluating the Efficacy of Capecitabine and Vinorelbine in Anthracycline and Taxane Pre-Treated Metastatic Breast Cancer
Study Start Date : September 2002
Actual Primary Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed breast cancer
  • Metastatic disease
  • Prior treatment with taxanes in the metastatic, adjuvant, or neoadjuvant setting

    • Taxane-resistant disease allowed regardless of duration of prior therapy NOTE: Resistant disease defined as progression during or within 12 weeks after taxane therapy for metastatic disease or a disease-free interval of less than 12 months after neoadjuvant or adjuvant therapy with a taxane
    • Taxane-sensitive disease allowed if at least 4 prior courses were received NOTE: Sensitive disease defined as progression occurring more than 12 weeks after taxane therapy for metastatic disease or more than 12 months after neoadjuvant or adjuvant therapy with a taxane
  • Prior treatment with anthracyclines for metastatic disease or as adjuvant treatment OR medical contraindication to treatment with anthracyclines
  • At least one unidimensionally measurable lesion (phase II study)
  • No CNS metastases
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Female

Menopausal status

  • Not specified

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified


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


  • Bilirubin no greater than 1.25 times upper limit of normal (ULN)
  • Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present)


  • Creatinine clearance greater than 50 mL/min


  • No symptomatic ventricular arrhythmias
  • No clinically significant congestive heart failure
  • No clinical or ECG evidence of myocardial infarction within the past 12 months
  • No significant coronary artery disease


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No prior malignancy within the past 5 years except contralateral breast cancer, nonmelanoma skin cancer, and adequately treated carcinoma in situ of the cervix
  • No known or prior sensitivity to fluoropyrimidines, including fluorouracil
  • No pre-existing grade 2 or greater neurotoxicity
  • No known malabsorption or upper gastrointestinal abnormalities that would affect absorption of study drug
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance


Biologic therapy

  • No concurrent biologic therapy


  • See Disease Characteristics
  • No more than 2 prior chemotherapy lines for metastatic disease
  • No prior capecitabine, vinca alkaloids, or continuous fluorouracil
  • No other concurrent chemotherapy

Endocrine therapy

  • Prior hormonal therapy allowed
  • No concurrent hormonal therapy


  • No concurrent radiotherapy


  • Not specified


  • Bisphosphonate therapy for treatment and prevention of bony metastases allowed if initiated prior to study
  • No other concurrent investigational treatment
  • No concurrent brivudine with capecitabine

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 identifier (NCT number): NCT00049660

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Ziekenhuis Network Antwerpen Middelheim
Antwerp, Belgium, 2020
Institut Jules Bordet
Brussels, Belgium, 1000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
Algemeen Ziekenhuis Sint-Augustinus
Wilrijk, Belgium, 2610
Institut Bergonie
Bordeaux, France, 33076
Centre Henri Becquerel
Rouen, France, 76038
Klinikum Nuernberg - Klinikum Sued
Nurberg, Germany, 90471
Institute of Oncology - Ljubljana
Ljubljana, Slovenia, Sl-1000
United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Western Infirmary
Glasgow, Scotland, United Kingdom, G11 6NT
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Martine J. Piccart-Gebhart, MD, PhD Jules Bordet Institute
Study Chair: Chris Twelves, MD, BMedSci, FRCP University of Glasgow
Publications of Results:
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00049660    
Other Study ID Numbers: EORTC-10001-160010
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 18, 2012
Last Verified: July 2012
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage IV breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators