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Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
capecitabine
vinorelbine tartrate
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 18 and over Sex Female Menopausal status Not specified Performance status Karnofsky 70-100% Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic 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) Renal Creatinine clearance greater than 50 mL/min Cardiovascular 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 Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent biologic therapy Chemotherapy 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 Radiotherapy No concurrent radiotherapy Surgery Not specified Other 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

Sites / Locations

  • Ziekenhuis Network Antwerpen Middelheim
  • Institut Jules Bordet
  • Universitair Ziekenhuis Antwerpen
  • Algemeen Ziekenhuis Sint-Augustinus
  • Institut Bergonie
  • Centre Henri Becquerel
  • Klinikum Nuernberg - Klinikum Sued
  • Institute of Oncology - Ljubljana
  • Cancer Research Centre at Weston Park Hospital
  • Western General Hospital
  • Beatson Oncology Centre
  • Western Infirmary

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 12, 2002
Last Updated
July 17, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00049660
Brief Title
Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
September 2002 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Phase II Study: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IV breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
vinorelbine tartrate

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 18 and over Sex Female Menopausal status Not specified Performance status Karnofsky 70-100% Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic 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) Renal Creatinine clearance greater than 50 mL/min Cardiovascular 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 Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent biologic therapy Chemotherapy 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 Radiotherapy No concurrent radiotherapy Surgery Not specified Other 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine J. Piccart-Gebhart, MD, PhD
Organizational Affiliation
Jules Bordet Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chris Twelves, MD, BMedSci, FRCP
Organizational Affiliation
University of Glasgow
Official's Role
Study Chair
Facility Information:
Facility Name
Ziekenhuis Network Antwerpen Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Algemeen Ziekenhuis Sint-Augustinus
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Klinikum Nuernberg - Klinikum Sued
City
Nurberg
ZIP/Postal Code
90471
Country
Germany
Facility Name
Institute of Oncology - Ljubljana
City
Ljubljana
ZIP/Postal Code
Sl-1000
Country
Slovenia
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Beatson Oncology Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Western Infirmary
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
17976988
Citation
Pajk B, Cufer T, Canney P, Ellis P, Cameron D, Blot E, Vermorken J, Coleman R, Marreaud S, Bogaerts J, Basaran G, Piccart M. Anti-tumor activity of capecitabine and vinorelbine in patients with anthracycline- and taxane-pretreated metastatic breast cancer: findings from the EORTC 10001 randomized phase II trial. Breast. 2008 Apr;17(2):180-5. doi: 10.1016/j.breast.2007.09.002. Epub 2007 Oct 31.
Results Reference
result
PubMed Identifier
34037241
Citation
Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
Results Reference
derived

Learn more about this trial

Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer

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