N/A
Completed N=167
A Study to Evaluate Safety and Tolerability in Patients With Metastatic Breast Cancer Receiving Treatment With Caelyx (Study P04878)(COMPLETED)
Breast Neoplasm
Source: ClinicalTrials.gov NCT00736333 ↗
Enrolled (actual)
167
Serious AEs
3.1%
Results posted
Jul 2011
Primary outcomePrimary: Number of Participants With Infusion Reactions (IR) — 7 Participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Infusion Reactions (IR) |
7 | — |
| PRIMARY Percent of Participants Taking Premedication for Prevention of IR |
96.3; 97.5; 15.6; 36.3 | — |
| PRIMARY Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR |
— | — |
| PRIMARY Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE) |
91 | — |
| PRIMARY Number of Times Premedications Were Given for Prevention of PPE |
66; 70; 49 | — |
| SECONDARY Number of Participants With Complete Response (CR) or Partial Response (PR) |
2; 29 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00736333). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.