Clinical trial · Interventional
Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer
A Randomized Phase II-III Trial Evaluating the Efficacy of Capecitabine and Vinorelbine in Anthracycline and Taxane Pre-Treated Metastatic Breast Cancer
NCT00049660CI-TRIAL-00007475terminatedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| vinorelbine tartrate | Drug | Vinorelbine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTPajk 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 17976988
- DERIVEDHoon 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 34037241