A Study to Evaluate Safety and Tolerability in Patients With Metastatic Breast Cancer Receiving Treatment With Caelyx (Study P04878)(COMPLETED)
This study has been completed.
Merck Sharp & Dohme Corp.
First Posted: August 15, 2008
Last Update Posted: November 5, 2014
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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).
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Observational Program of Caelyx in MBC - Prevention and Treatment of PPE and Infusion Reactions|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Number of Participants With Infusion Reactions (IR) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Day 1 up to 24 weeks ]Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications.
Secondary Outcome Measures:
- Number of Participants With Complete Response (CR) or Partial Response (PR) [ Time Frame: Day 1 up to 24 weeks ]CR and PR were documented according to the clinical standards of each site.
|Study Start Date:||November 2006|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Pegylated Liposomal Doxorubicin
Subjects with metastatic breast cancer
Drug: Pegylated Liposomal Doxorubicin
Pegylated Liposomal Doxorubicin (Caelyx) 50 mg/m^2, given for up to 6 cycles
Other Name: SCH 200746
Patients selected by investigator according to clinical routine
Contacts and Locations
No Contacts or Locations Provided