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

Completed

• Conditions: Breast Neoplasm
• Interventions: Drug: Pegylated Liposomal Doxorubicin

• Registration Number: NCT00736333
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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).

Detailed Description

Patients selected by investigator according to clinical routine

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-08-14
• Study First Posted: 2008-08-15
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Results First Submitted: 2011-06-13
• Results First Submitted QC: 2011-06-13
• Results First Posted: 2011-07-07
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-31
• Last Update Posted: 2014-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

Inclusion Criteria

• Patients with metastatic breast cancer

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Exclusion Criteria

• History of hypersensitivity to Caelyx or its components
• Women who are pregnant or breast-feeding
• Patients with severe myelosuppression

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pegylated Liposomal Doxorubicin	Pegylated Liposomal Doxorubicin	Subjects with metastatic breast cancer

Primary Outcome Measures

Name	Time	Method
Number of Participants With Infusion Reactions (IR)	Day 1 up to Week 24	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.
Percent of Participants Taking Premedication for Prevention of IR	Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin	Premedications for prevention of IR included corticosteroids, serotonin-3 receptor antagonists (anti-emetics), histamine-1 receptor blockers, and histamine-2 receptor blockers.
Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR	Cycles 1 & 3 (Week 4 & Week 12)	Allergic conditions included food allergies, drug allergies, allergic rhinitis, histamine allergy, neurodermatitis, and chronic idiopathic urticaria.
Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE)	Up to 24 weeks	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.
Number of Times Premedications Were Given for Prevention of PPE	Day 1 up to 24 weeks	Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Complete Response (CR) or Partial Response (PR)	Day 1 up to 24 weeks	CR and PR were documented according to the clinical standards of each site.