Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: July 25, 2008
Last updated: October 31, 2014
Last verified: October 2014

July 25, 2008
October 31, 2014
November 2006
June 2010   (final data collection date for primary outcome measure)
  • 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.
Safety; Tolerability; Analysis of data. [ Time Frame: Data will be collected monthly during 6 cycles ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00736333 on Archive Site
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.
Overall response rate [ Time Frame: Monthly during 6 cycles ] [ Designated as safety issue: No ]
Not Provided
Not Provided
A Study to Evaluate Safety and Tolerability in Patients With Metastatic Breast Cancer Receiving Treatment With Caelyx (Study P04878)(COMPLETED)
Observational Program of Caelyx in MBC - Prevention and Treatment of PPE and Infusion Reactions

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

Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with metastatic breast cancer

Breast Neoplasm
Drug: Pegylated Liposomal Doxorubicin
Pegylated Liposomal Doxorubicin (Caelyx) 50 mg/m^2, given for up to 6 cycles
Other Name: SCH 200746
Pegylated Liposomal Doxorubicin
Subjects with metastatic breast cancer
Intervention: Drug: Pegylated Liposomal Doxorubicin
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Not Provided
Contact information is only displayed when the study is recruiting subjects
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP