Clinical trial · Interventional
Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer (MBC)
Randomized Multicenter Phase II Study of Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine as First Line Chemotherapy for Patients With Metastatic Breast Cancer
NCT00629148CI-TRIAL-00005175completedPhase 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)
The primary objective of this study is to evaluate the efficacy and tolerability of sequential use of vinorelbine and capecitabine as first line therapy in patients with MBC.
Conditions
Conditions (2)
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 |
| Metastasis, Neoplasm | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vinorelbine and Capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- combination chemotherapy
- description
- Simultaneous use of Vinorelbine and Capecitabine
- interventionNames
- Drug: Vinorelbine and Capecitabine
- type
- EXPERIMENTAL
- label
- sequential chemotherapy
- description
- Sequential use of Vinorelbine and Capecitabine
- interventionNames
- Drug: Vinorelbine and Capecitabine
Primary outcomes (1)
- measure
- PFS(progression-free survival,defined as the time period between randomization and disease progress or death) and TTF (time to treatment failure, defined as all discontinuations for any cause)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent. * Female, ≥ 18 and ≤ 70 years. * Histologically confirmed invasive breast cancer. * Metastatic breast cancer. * ECOG Performance Status of 0 to 2. * Life expectancy of more than 3 months. * Subject must have adequate organ function. * Normal laboratory values: hemoglobin \> 90g/dl, neutrophils \> 1.5×10\^9/L, platelets \> 80×10\^9/L, serum creatinine \< 1.5×upper limit of normal (ULN), serum bilirubin \< 1.5×ULN, ALT and AST \< 2.5×ULN. * Negative serum pregnancy test for women with childbearing potential. * Good conditions for infusion and willing to have phlebotomy throughout whole study. * Have ceased anti-tumor treatments including endocrinotherapy and bio-targeted therapy for more than 28 days. * Have at least one target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Exclusion Criteria: * Pregnant or lactating females * History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible * Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety * Active or uncontrolled infection * Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure * Concomitant with brain metastases * Have received chemotherapy after metastasis
References
Publications (0)
Data not yet available
No reference posted for this study.