Clinical trial · Interventional
XRP9881 in Combination With Trastuzumab in Metastatic Breast Cancer
Open Label, Uncontrolled Study of XRP9881 in Combination With Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)
NCT00386685CI-TRIAL-00004672completedPhase 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 the study is to assess the activity of XRP9881 in combination with trastuzumab. The secondary objectives are safety and pharmacokinetic interaction
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| larotaxel (XRP9881) | Drug | — | UNRESOLVED |
| trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate (best overall response under treatment)
- timeFrame
- study period
Secondary outcomes (1)
- measure
- Incidence of grade 3-4 toxicities, pharmacokinetic interaction
- timeFrame
- study period
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic breast cancer (MBC) * HER2 (Human Epidermal Growth Factor Receptor 2) positive: FISH (Fluorescent In Situ Hybridization) positive or IHC (Immunohistochemistry) 3+ * Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) * Adequate organs functions Exclusion Criteria: * More than one previous chemotherapy regimen for metastatic disease * Cardiac dysfunction
References
Publications (0)
Data not yet available
No reference posted for this study.