Clinical trial · Interventional
VinCaT: Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer
Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer, a Phase 2 Study
NCT00431704CI-TRIAL-00064986VinCaTunknownPhase 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 purpose of this study is to evaluate the activity and safety of the combination of vinorelbine, carboplatin and trastuzumab in HER2-positive metastatic 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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| trastuzumab | Drug | Trastuzumab | ALIAS |
| vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- vinorelbine, carboplatin, trastuzumab
- interventionNames
- Drug: vinorelbine
- Drug: carboplatin
- Drug: trastuzumab
Primary outcomes (2)
- measure
- objective response rate
- timeFrame
- after 3 and 6 cycles of therapy
- measure
- side effects
- timeFrame
- after every cycle of therapy
Secondary outcomes (2)
- measure
- time to progression
- timeFrame
- at 12 months, end of study
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological diagnosis of breast cancer * Stage IV disease * None or at most one prior treatment for metastatic disease (prior treatment with trastuzumab for metastatic disease is not permitted) * Overexpression of HER-2 (immunohistochemistry 3+) or genetic amplification of c-erbB2/neu (FISH+) * ECOG Performance Status 0-2 * Age \>18 and \< 75 years * Left Ventricular Ejection Fraction (LVEF) \>50% * Life expectancy \>3 months * Signed informed consent Exclusion Criteria: * Absence of measurable or evaluable disease * Life expectancy \< 3 months * ECOG performance status \> 2 * History of prior malignancy in the last 5 years (other than adequately treated non-melanoma skin cancer or excised cervical carcinoma in situ). * Previous chemotherapy with vinorelbine or carboplatin (as adjuvant therapy or for metastatic disease) * Previous therapy with trastuzumab for metastatic disease (previous adjuvant therapy with trastuzumab is permitted) * Neutrophil \< 2000/mm3, platelets \< 100,000/mm3, haemoglobin \< 9 g/dl * Creatinine \> 1.5 x the upper normal limits * GOT and/or GPT \> 2.5 x the upper normal limits and/or Bilirubin \> 1.5 x the upper normal limits in absence of hepatic metastases * GOT and/or GPT \> 5 x the upper normal limits and/or Bilirubin \> 3 x the upper normal limits in presence of hepatic metastases * Congestive hearth failure or history of congestive heart failure, unstable angina pectoris even if it is medically controlled, myocardial infarction, clinically significant valve disease, uncontrolled arrhythmia * Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study * Male gender * Pregnant or lactating women * Refusal or incapacity to provide informed consent * Inability to comply with follow up
References
Publications (0)
Data not yet available
No reference posted for this study.