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| Sponsor: | European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00049660 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: capecitabine Drug: vinorelbine ditartrate |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| 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 |
OBJECTIVES: Phase II Study:
Phase III Study:
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.
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Prior treatment with taxanes in the metastatic, adjuvant, or neoadjuvant setting
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| Belgium | |
| Algemeen Ziekenhuis Sint-Augustinus | |
| Wilrijk, Belgium, 2610 | |
| Institut Jules Bordet | |
| Brussels, Belgium, 1000 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| Ziekenhuis Network Antwerpen Middelheim | |
| Antwerp, Belgium, 2020 | |
| France | |
| Centre Henri Becquerel | |
| Rouen, France, 76038 | |
| Institut Bergonie | |
| Bordeaux, France, 33076 | |
| Germany | |
| Klinikum Nuernberg - Klinikum Sued | |
| Nurberg, Germany, 90471 | |
| Slovenia | |
| Institute of Oncology - Ljubljana | |
| Ljubljana, Slovenia, Sl-1000 | |
| United Kingdom, England | |
| Cancer Research Centre at Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| United Kingdom, Scotland | |
| Beatson Oncology Centre | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| Western General Hospital | |
| Edinburgh, Scotland, United Kingdom, EH4 2XU | |
| Western Infirmary | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| Investigator: | Martine J. Piccart-Gebhart, MD, PhD | Institut Jules Bordet |
| Investigator: | Chris Twelves, MD, BMedSci, FRCP | University of Glasgow |
More Information
| Study ID Numbers: | CDR0000258144, EORTC-10001, EORTC-16001O, IDBBC-EORTC-10001 |
| Study First Received: | November 12, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00049660 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer |
|
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Mitosis Modulators Breast Neoplasms Vinblastine |
Antimitotic Agents Pharmacologic Actions Neoplasms Neoplasms by Site Vinorelbine Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic Breast Diseases |