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Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement

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: NCT00003902
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 15, 2012
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine and vinorelbine and to see how well they work in treating older women with metastatic breast cancer with or without bone involvement.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: capecitabine Drug: vinorelbine tartrate Phase 1 Phase 2

Detailed Description:


  • Determine the maximum tolerated dose of capecitabine and vinorelbine in elderly women (65 and older) with metastatic breast cancer.
  • Evaluate the efficacy and tolerability of this regimen in these patients.
  • Assess the time to treatment failure for this regimen as a first line chemotherapy in these patients.

OUTLINE: This is a dose-escalation study of capecitabine and vinorelbine. Patients are stratified according to bone involvement (yes [closed to accrual as of 12/7/04] vs no).

  • Phase I: Patients receive oral capecitabine twice daily on days 1-14 and vinorelbine IV over 6-10 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of capecitabine and vinorelbine until the maximum tolerated dose (MTD) of each drug is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity.

  • Phase II: Patients receive capecitabine and vinorelbine administered as in phase I, at the dose preceding the MTD.

Quality of life is assessed during phase II on days 1, 8, and 15 of course 1 and on day 1 of courses 2-4.

Patients are followed every 3 months until disease progression or start of any subsequent antitumor treatment.

PROJECTED ACCRUAL: A total of 98-110 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Primary Purpose: Treatment
Official Title: Phase I/II of Capecitabine and Vinorelbine in Elderly Patients (At Least 65 Years) With Metastatic Breast Cancer With or Without Bone Involvement
Study Start Date : March 1999
Actual Primary Completion Date : December 2004
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Maximum-tolerated dose (phase I)
  2. Response rate at the end of study treatment (phase II)
  3. Toxicity at the end of study treatment (phase II)

Secondary Outcome Measures :
  1. Time to treatment failure at end of study treatment (phase II)
  2. Quality of life by Linear Analogue Self-Assessment indicators with 6 assessments until the end of the course 4 (phase II)

Information from the National Library of Medicine

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


  • Histologically or cytologically proven adenocarcinoma of the breast
  • Phase I: Measurable or evaluable disease
  • Phase II: Bidimensionally measurable disease
  • No CNS metastases
  • Hormone receptor status:

    • Not specified



  • 65 and over


  • Female

Menopausal status:

  • Postmenopausal

Performance status:

  • ECOG/SAKK 0-2

Life expectancy:

  • At least 12 weeks


  • Normal peripheral blood counts


  • AST no greater than 2 times upper limit of normal (ULN) (no greater than 3 times ULN if liver metastases present)


  • Creatinine no greater than 1.5 times ULN


  • No other prior or concurrent malignancy except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
  • No peripheral neuropathy grade 2 or higher
  • No cognitive impairment or severe psychiatric disorder


Biologic therapy:

  • Not specified


  • More than 6 months since prior adjuvant chemotherapy
  • No prior chemotherapy for metastatic or locally advanced disease
  • No other concurrent chemotherapy

Endocrine therapy:

  • Prior hormonal therapy for metastatic disease allowed
  • No continuous concurrent steroids
  • No concurrent systemic endocrine therapy for breast cancer
  • No other concurrent endocrine therapy


  • No concurrent radiotherapy involving greater than 30% of bone marrow or mucosa
  • Radiotherapy to nonindicator lesion allowed


  • Not specified


  • Bisphosphonates allowed if indicator lesion in nonbone site

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): NCT00003902

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Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
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Study Chair: Dagmar Hess, MD Cantonal Hospital of St. Gallen
Publications of Results:
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Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT00003902    
Other Study ID Numbers: SAKK 25/99
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012
Keywords provided by Swiss Group for Clinical Cancer Research:
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