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| Sponsor: | European Organization for Research and Treatment of Cancer - EORTC |
|---|---|
| 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 tartrate |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | 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 |
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 | |
| 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 | |
| France | |
| Institut Bergonie | |
| Bordeaux, France, 33076 | |
| Centre Henri Becquerel | |
| Rouen, France, 76038 | |
| Germany | |
| Klinikum Nuernberg - Klinikum Sued | |
| Nurberg, Germany, 90471 | |
| Slovenia | |
| 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 | |
| Investigator: | Martine J. Piccart-Gebhart, MD, PhD | Institut Jules Bordet |
| Investigator: | Chris Twelves, MD, BMedSci, FRCP | University of Glasgow |
More Information
| ClinicalTrials.gov Identifier: | NCT00049660 History of Changes |
| Other Study ID Numbers: | CDR0000258144, EORTC-10001, EORTC-16001O, IDBBC-EORTC-10001 |
| Study First Received: | November 12, 2002 |
| Last Updated: | February 26, 2011 |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Vinorelbine Vinblastine Capecitabine Fluorouracil Antineoplastic Agents, Phytogenic Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |