Clinical trial · Interventional
Phase II Trial With Metronomic, Capecitabine Plus Oral Vinorelbine for Metastatic Breast Cancer
Randomized Phase II Trial of Capecitabine Plus Oral Vinorelbine Day 1 and 8 vs Metronomic Capecitabine Plus Oral Vinorelbine as Treatment of Metastatic Breast Cancer.
NCT01941771CI-TRIAL-00024502XeNacompletedPhase 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 study hypothesis is that metronomic treatment is more efficient than standard treatment.
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 |
|---|---|---|---|
| Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda) | Drug | — | UNRESOLVED |
| Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- Vinorelbine (Navelbine Oral) 60 mg/m2 day 1 and day 8 Plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1 to 14 in a 3 weekly schedule.
- interventionNames
- Drug: Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda)
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Oral Vinorelbine (Navelbine oral) 50 mg 3 times weekly, monday, wednesday and friday plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1-14 in a 3 weekly schedule.
- interventionNames
- Drug: Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda)
Primary outcomes (1)
- measure
- Primary endpoint is overall response rate i both arms.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Locally advanced or metastatic Human Epidermal Growth Factor Receptor2-Negative breast cancer * WHO performance status \< 3 Exclusion Criteria: * Former treatment with Capecitabine or Vinorelbine * Patients who have received more than one line of chemotherapy for metastatic disease * Brain metastases * Malabsorption syndrome * Abnormal organ function * pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.