Clinical trial · Interventional
Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer
A Phase I Study of Oral Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer
NCT00153907CI-TRIAL-00009345completedPhase 1ClinicalTrials.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)
The purpose of this study is to find the highest dose of capecitabine and oral navelbine that can be given without causing severe side effects, and to determine the safety, tolerability, and effects (good and bad) of capecitabine given with oral navelbine to patients with advanced 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Navelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To define the maximally tolerated dose and evaluate the feasibility and toxicity of capecitabine and oral navelbine administered in combination.
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed breast cancer with evidence of locally advanced or metastatic disease * Female patients age 18 or older * No more than three prior chemotherapeutic regimens in the metastatic setting * ANC \> 1,500/mm3 * Platelet count \> 100,000/mm3 * SGOT \< 3 x ULN * Bilirubin \< 1.5 x ULN * Performance status of 0 or 1 * At least 3 weeks since prior chemotherapy or 2 weeks since prior radiation, surgery or any anticancer investigational agent * Able to swallow and retain oral medications * Measurable disease Exclusion Criteria: * Prior vinca alkaloids * Active gastrointestinal disease or disorder * Pregnant or lactating * Serious co-morbid medical or psychological condition * Prior bone marrow or stem cell transplant * Prior documented severe sensitivity to 5-FU
References
Publications (0)
Data not yet available
No reference posted for this study.