A Study to Evaluate Safety and Tolerability in Patients With Metastatic Breast Cancer Receiving Treatment With Caelyx (Study P04878)(COMPLETED)

Study Overview
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Brief Summary
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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).

Detailed Description
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Patients selected by investigator according to clinical routine

Official Title
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Observational Program of Caelyx in MBC - Prevention and Treatment of PPE and Infusion Reactions

Conditions
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Breast Neoplasm

Intervention / Treatment
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* Drug: Pegylated Liposomal Doxorubicin


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pegylated Liposomal Doxorubicin<br>Subjects with metastatic breast cancer | Drug: Pegylated Liposomal Doxorubicin<br>* Pegylated Liposomal Doxorubicin (Caelyx) 50 mg/m^2, given for up to 6 cycles<br>* Other names: SCH 200746;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Infusion Reactions (IR) | 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. | Day 1 up to Week 24 | 
| Percent of Participants Taking Premedication for Prevention of IR | Premedications for prevention of IR included corticosteroids, serotonin-3 receptor antagonists (anti-emetics), histamine-1 receptor blockers, and histamine-2 receptor blockers. | Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin | 
| Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR | Allergic conditions included food allergies, drug allergies, allergic rhinitis, histamine allergy, neurodermatitis, and chronic idiopathic urticaria. | Cycles 1 & 3 (Week 4 & Week 12) | 
| Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE) | PPE was defined as a dermatological adverse event characterized by swelling, pain, edema, erythema, desquamation, that may have ultimately resulted in fissuring and ulceration, involving fingers, toes, palms, plantar aspects of the feet, and other pressure-sensitive areas of the skin. | Up to 24 weeks | 
| Number of Times Premedications Were Given for Prevention of PPE | Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications. | Day 1 up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Complete Response (CR) or Partial Response (PR) | CR and PR were documented according to the clinical standards of each site. | Day 1 up to 24 weeks |