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

Merck Sharp & Dohme LLC167 enrolled

Overview

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).

Patients selected by investigator according to clinical routine

Study Type

OBSERVATIONAL

Enrollment

167

Conditions

Breast Neoplasm

Interventions

Pegylated Liposomal DoxorubicinDRUG

Pegylated Liposomal Doxorubicin (Caelyx) 50 mg/m\^2, given for up to 6 cycles

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Day 1 up to 24 weeks

Secondary Outcomes

Number of Participants With Complete Response (CR) or Partial Response (PR)

Data from ClinicalTrials.gov

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