Clinical trial · Observational
Drug Use Investigation for TYKERB Tablet (All Case Investigation)
NCT01332396CI-TRIAL-00027192completedClinicalTrials.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)
Data on the safety and efficacy of TYKERB shall be collected from the patients in order to grasp the actual conditions of post-marketing use and assess background information on the patients.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lapatinib | Drug | Lapatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Patients prescribed TYKERB
- description
- Patients with HER2 overexpressing inoperable or recurrent breast cancer
- interventionNames
- Drug: Lapatinib
Primary outcomes (1)
- measure
- The incidence of adverse events in Japanese patients treated with TYKERB based on prescribing information under the conditions of general clinical practice
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with HER2 overexpressing inoperable or recurrent breast cancer Exclusion Criteria: * Patients with hypersensitivity to lapatinib or any components * Pregnant women and women suspected of being pregnant
References
Publications (0)
Data not yet available
No reference posted for this study.