Clinical trial · Interventional
Dose Finding Study for Combination of Capecitabine, Lapatinib and Vinorelbine in Metastatic Breast Cancer
Combinational Therapy of Capecitabine, Lapatinib and Vinorelbine for the Treatment of Patients With her2/Neu Positive, Relapsed or Metastatic Breast Carcinoma Following Treatment Failure With Trastuzumab
NCT01238029CI-TRIAL-00016127CELAVIEterminatedPhase 1ClinicalTrials.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): new methods of treatment, no more patients appilicable for study
Summary
Brief summary (as posted)
The purpose of the study is to investigate safety and efficiency of the triple combination of capecitabine, lapatinib and vinorelbine in patients with metastatic breast cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Failure or Contraindication of Trastuzumab Therapy | — | UNRESOLVED | — |
| First or Second Line Therapy | — | UNRESOLVED | — |
| HER2 Positive | — | UNRESOLVED | — |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lapatinib and Capecitabine and Vinorelbine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Capecitabine, Lapatinib, Vinorelbine
- interventionNames
- Drug: Lapatinib and Capecitabine and Vinorelbine
Primary outcomes (1)
- measure
- Identification of maximal tolerable Dose (MTD) of combination with Capecitabine and Lapatinib and Vinorelbine
- timeFrame
- 4 months
- description
- Phase I: Identification of Dosis limiting toxicities and maximal tolerable dose for Combinational therapy (Time Frame: within the first 21 days under medication)
Secondary outcomes (4)
- measure
- Overall response Rate
- timeFrame
- 12 months
- description
- Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Written informed consent * Able to comply with the protocol * ECOG performance status 0-1 * Adequate contraception * Confirmed Her2/neu-positive, adenocarcinoma of the breast * At least one measurable lesion according to RECIST 1.1 criteria * First or second chemotherapy after diagnosis of metastasis * Lapatinib treatment indicated (adjuvant trastuzumab treatment \<12 months ago or progressive disease with trastuzumab treatment) * No signs and symptoms of CHF (chronic heart failure), LVEF (left ventricular ejection fraction) at study start at least 55% * Adequate hepatic and renal function value * Adequate hematologic function values Exclusion Criteria: * Pregnant or lactating women * Concurrent participation in another clinical trial. Prior participation is allowed if the last study medication was administered more than 4 weeks prior to randomization * Asymptomatic with regards to tumor illness * Previous treatment with lapatinib, capecitabine or vinorelbine * Necessity of planned treatment with other chemotherapeutics oder anti-hormone therapy * Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study * Evidence of cardiovascular disease, e.g. myocardial infection, unstable angina pectoris or arrhythmia * History of vascular or cardiovascular disease within the past 6 months * All illnesses that result in malabsorption of oral medication or inability to take oral medication * Concurrent treatment with anti-viral drugs based on sorivudine or with aminoglycosides * Concurrent treatment with any drug interfering with study medication, especially, those that induce CYP3A * Concurrent treatment with allopurinol * Other malignancies (except for basal cell carcinoma of the skin and cervical carcinoma in situ); patient can be included in the study if no recurrent disease has been observed for at least 5 years * Concurrent illnesses or other circumstances that could interfere with trial participation, efficacy or safety of the patient
References
Publications (0)
Data not yet available
No reference posted for this study.