Clinical trial · Observational
A Study to Evaluate Safety and Tolerability in Patients With Metastatic Breast Cancer Receiving Treatment With Caelyx (Study P04878)(COMPLETED)
Observational Program of Caelyx in MBC - Prevention and Treatment of PPE and Infusion Reactions
NCT00736333CI-TRIAL-00015991completedResults postedClinicalTrials.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 study to evaluate the safety and tolerability of Caelyx used for the treatment of metastatic breast cancer (MBC), focusing on infusion reaction and palmar-plantar erythrodysesthesia (PPE).
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 Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pegylated Liposomal Doxorubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Pegylated Liposomal Doxorubicin
- description
- Subjects with metastatic breast cancer
- interventionNames
- Drug: Pegylated Liposomal Doxorubicin
Primary outcomes (5)
- measure
- Number of Participants With Infusion Reactions (IR)
- timeFrame
- Day 1 up to Week 24
- description
- Infusion reaction was defined as an allergic reaction or anaphylactoid reaction characterized by shortness of breath, hypotension, back pain, chest pain, chills, flush, sweating, fever, nausea, dizziness, rash, pruritis, or tachycardia.
- measure
- Percent of Participants Taking Premedication for Prevention of IR
- timeFrame
- Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin
- description
- Premedications for prevention of IR included corticosteroids, serotonin-3 receptor antagonists (anti-emetics), histamine-1 receptor blockers, and histamine-2 receptor blockers.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with metastatic breast cancer Exclusion Criteria: * History of hypersensitivity to Caelyx or its components * Women who are pregnant or breast-feeding * Patients with severe myelosuppression
References
Publications (0)
Data not yet available
No reference posted for this study.