Clinical trial · Interventional
Vinorelbine in Treating Older Women With Stage IV Breast Cancer
Phase II Trial of Oral Vinorelbine for the Treatment of Metastatic Breast Cancer in Patients >65 Years of Age: A Trial of Efficacy, Toxicity, and Patients' Perceived Preference for Oral Therapy
NCT00022152CI-TRIAL-00022880completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
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. PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating older women who have stage IV breast cancer.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vinorelbine tartrate | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- vinorelbine
- description
- Patients receive oral vinorelbine once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then after completion of the second course. Patients are followed every 3 months for 5 years.
- interventionNames
- Drug: vinorelbine tartrate
Primary outcomes (1)
- measure
- objective response rate
- timeFrame
- Up to 5 years
Secondary outcomes (2)
- measure
- time to progression
- timeFrame
- Up to 5 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed stage IV breast cancer * Eligible to receive first- or second-line chemotherapy * At least 1 unidimensionally measurable lesion * At least 20 mm in longest diameter * Must be completely outside prior irradiation port unless there is proof of progressive disease after completion of prior radiotherapy * No untreated brain metastases * Current metastatic CNS disease allowed only if previously treated and clinically stable at study entry * No meningeal carcinomatosis * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 65 and over Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR * Direct bilirubin normal if total bilirubin elevated or less than 2.5 times ULN because of Gilbert's syndrome Renal: * Creatinine no greater than 2 times ULN Other: * No grade 2 or greater peripheral neuropathy * No other significant medical condition that would preclude study * No active infection within the past 2 weeks * No dysphagia or inability to swallow intact capsules PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No more than 1 prior chemotherapy regimen for metastatic disease * No prior vinca alkaloids * At least 4 weeks since other prior chemotherapy and recovered Endocrine therapy: * Prior hormonal therapy allowed * No concurrent hormonal therapy Radiotherapy: * See Disease Characteristics * No prior radiotherapy to 25% or more of bone marrow * At least 3 weeks since prior radiotherapy and recovered Surgery: * At least 3 weeks since prior major surgery
References
Publications (1)
- RESULTBaweja M, Suman VJ, Fitch TR, Mailliard JA, Bernath A, Rowland KM, Alberts SR, Kaur JS, Perez EA; NCCTG. Phase II trial of oral vinorelbine for the treatment of metastatic breast cancer in patients > or = 65 years of age: an NCCTG study. Ann Oncol. 2006 Apr;17(4):623-9. doi: 10.1093/annonc/mdj130. Epub 2006 Mar 6. PMID 16520332