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

Breast Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736333
• Other study ID #: P04878
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: October 31, 2014
• Start date: November 2006
• Est. completion date: June 2010

Study information

• Verified date: October 2014
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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).

Description:

Patients selected by investigator according to clinical routine

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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)	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	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	No