Clinical trial · Interventional
Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement
Phase I/II of Capecitabine and Vinorelbine in Elderly Patients (At Least 65 Years) With Metastatic Breast Cancer With or Without Bone Involvement
NCT00003902CI-TRIAL-00006900completedPhase 1 / Phase 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. Combining more than one drug may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine and vinorelbine and to see how well they work in treating older women with metastatic breast cancer with or without bone involvement.
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 |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Maximum-tolerated dose (phase I)
- measure
- Response rate at the end of study treatment (phase II)
- measure
- Toxicity at the end of study treatment (phase II)
Secondary outcomes (2)
- measure
- Time to treatment failure at end of study treatment (phase II)
- measure
- Quality of life by Linear Analogue Self-Assessment indicators with 6 assessments until the end of the course 4 (phase II)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically proven adenocarcinoma of the breast * Phase I: Measurable or evaluable disease * Phase II: Bidimensionally measurable disease * No CNS metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 65 and over Sex: * Female Menopausal status: * Postmenopausal Performance status: * ECOG/SAKK 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Normal peripheral blood counts Hepatic: * AST no greater than 2 times upper limit of normal (ULN) (no greater than 3 times ULN if liver metastases present) Renal: * Creatinine no greater than 1.5 times ULN Other: * No other prior or concurrent malignancy except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix * No peripheral neuropathy grade 2 or higher * No cognitive impairment or severe psychiatric disorder PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * More than 6 months since prior adjuvant chemotherapy * No prior chemotherapy for metastatic or locally advanced disease * No other concurrent chemotherapy Endocrine therapy: * Prior hormonal therapy for metastatic disease allowed * No continuous concurrent steroids * No concurrent systemic endocrine therapy for breast cancer * No other concurrent endocrine therapy Radiotherapy: * No concurrent radiotherapy involving greater than 30% of bone marrow or mucosa * Radiotherapy to nonindicator lesion allowed Surgery: * Not specified Other: * Bisphosphonates allowed if indicator lesion in nonbone site
References
Publications (2)
- RESULTHess D, Koberle D, Thurlimann B, Pagani O, Schonenberger A, Mattmann S, Rochlitz C, Rauch D, Schuller JC, Ballabeni P, Ribi K; Swiss Group for Clinical Cancer Research. Capecitabine and vinorelbine as first-line treatment in elderly patients (> or =65 years) with metastatic breast cancer. A phase II trial (SAKK 25/99). Oncology. 2007;73(3-4):228-37. doi: 10.1159/000127414. Epub 2008 Apr 17. PMID 18424887
- RESULTHess D, Thurlimann B, Pagani O, Aebi S, Rauch D, Ballabeni P, Rufener B, Castiglione-Gertsch M, Goldhirsch A; Swiss Group of Clinical Cancer Research (SAKK). Capecitabine and vinorelbine in elderly patients (> or =65 years) with metastatic breast cancer: a phase I trial (SAKK 25/99). Ann Oncol. 2004 Dec;15(12):1760-5. doi: 10.1093/annonc/mdh467. PMID 15550580