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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00736333
Recruitment Status : Completed
First Posted : August 15, 2008
Results First Posted : July 7, 2011
Last Update Posted : November 5, 2014
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

July 25, 2008
August 15, 2008
June 13, 2011
July 7, 2011
November 5, 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 ]
    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.
Safety; Tolerability; Analysis of data. [ Time Frame: Data will be collected monthly during 6 cycles ]
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 ]
CR and PR were documented according to the clinical standards of each site.
Overall response rate [ Time Frame: Monthly during 6 cycles ]
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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
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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
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*   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
Sexes Eligible for Study: All
Child, Adult, Older Adult
Contact information is only displayed when the study is recruiting subjects
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Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
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Merck Sharp & Dohme Corp.
October 2014