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.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00736333

First received: July 25, 2008

Last updated: June 13, 2011

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	July 25, 2008
Last Updated Date	June 13, 2011
Start Date ^ICMJE	November 2006
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 13, 2011)	Number of Participants With Infusion Reactions (IR) [ Time Frame: Day 1 up to Week 24 ] [ Designated as safety issue: Yes ] 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 ] [ Designated as safety issue: Yes ] 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) ] [ Designated as safety issue: Yes ] 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 ] [ Designated as safety issue: Yes ] 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 ] [ Designated as safety issue: Yes ] Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications.
Original Primary Outcome Measures ^ICMJE (submitted: August 14, 2008)	Safety; Tolerability; Analysis of data. [ Time Frame: Data will be collected monthly during 6 cycles ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00736333 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 13, 2011)	Number of Participants With Complete Response (CR) or Partial Response (PR) [ Time Frame: Day 1 up to 24 weeks ] [ Designated as safety issue: No ] CR and PR were documented according to the clinical standards of each site.
Original Secondary Outcome Measures ^ICMJE (submitted: August 14, 2008)	Overall response rate [ Time Frame: Monthly during 6 cycles ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Evaluate Safety and Tolerability in Patients With Metastatic Breast Cancer Receiving Treatment With Caelyx (Study P04878)(COMPLETED)
Official Title ^ICMJE	Observational Program of Caelyx in MBC - Prevention and Treatment of PPE and Infusion Reactions
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 Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients with metastatic breast cancer
Condition ^ICMJE	Breast Neoplasm
Intervention ^ICMJE	Drug: Pegylated Liposomal Doxorubicin Pegylated Liposomal Doxorubicin (Caelyx) 50 mg/m^2, given for up to 6 cycles Other Name: SCH 200746
Study Group/Cohort (s)	Pegylated Liposomal Doxorubicin Subjects with metastatic breast cancer Intervention: Drug: Pegylated Liposomal Doxorubicin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	167
Completion Date	June 2010
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00736333
Other Study ID Numbers ^ICMJE	P04878
Has Data Monitoring Committee	No
Responsible Party	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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