Clinical trial · Observational
Halaven Post-Marketing Surveillance (PMS)
Post-Marketing Surveillance of Halaven Injection in Korean Patients
NCT02441764CI-TRIAL-00043914completedClinicalTrials.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)
This is a PMS to observe the safety profile of Halaven in normal clinical practice setting.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Halaven
- description
- Participants who are prescribed with Halaven per approved prescribing information of Halaven.
Primary outcomes (1)
- measure
- Safety of Halaven as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions
- timeFrame
- Up to 1 year
Secondary outcomes (1)
- measure
- Tumor response to Halaven treatment
- timeFrame
- Up to 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Participants who are prescribed with Halaven per approved prescribing information of Halaven will be enrolled in the study. This study will be conducted as complete surveillance method; participants who meet the inclusion/exclusion criteria and administrate Halaven for the first time after conclusion of agreement will be enrolled after consent. Inclusion Criteria: Participants who meet all of the following criteria will be eligible for inclusion in the study: 1. Participants with following indication: Participants with locally advanced or metastatic breast cancer who have previously received at least two chemotherapeutic regimens which should have included an anthracycline and a taxane. 2. Participants who have verbal or written consent for use of personal and medical information. Investigators will refer to indications regarding inclusion criteria. Exclusion Criteria: 1. Hypersensitivity to the active substance or to any of the excipients 2. Breast feeding 3. Pregnancy Investigators will refer to indications and contraindications regarding exclusion criteria.
References
Publications (0)
Data not yet available
No reference posted for this study.