NCT00049660

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.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Geographic Reach
5 countries

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2002

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Last Updated

July 18, 2012

Status Verified

July 1, 2012

Enrollment Period

2.3 years

First QC Date

November 12, 2002

Last Update Submit

July 17, 2012

Conditions

Breast Cancer

Keywords

stage IV breast cancer

Interventions

capecitabineDRUG
vinorelbine tartrateDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (12)

Ziekenhuis Network Antwerpen Middelheim

Antwerp, 2020, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

Algemeen Ziekenhuis Sint-Augustinus

Wilrijk, 2610, Belgium

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Klinikum Nuernberg - Klinikum Sued

Nurberg, 90471, Germany

Location

Institute of Oncology - Ljubljana

Ljubljana, Sl-1000, Slovenia

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Beatson Oncology Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Western Infirmary

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 17976988RESULT

  • 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.

    PMID: 34037241DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CapecitabineVinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Martine J. Piccart-Gebhart, MD, PhD

    Jules Bordet Institute

    STUDY CHAIR

  • Chris Twelves, MD, BMedSci, FRCP

    University of Glasgow

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2002

First Posted

January 27, 2003

Study Start

September 1, 2002

Primary Completion

December 1, 2004

Last Updated

July 18, 2012

Record last verified: 2012-07

Locations

FR(2)SL(1)DE(1)GB(4)BE(4)