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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 (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00736333
First received: July 25, 2008
Last updated: October 31, 2014
Last verified: October 2014
Results First Received: June 13, 2011  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Breast Neoplasm
Intervention: Drug: Pegylated Liposomal Doxorubicin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Pegylated Liposomal Doxorubicin Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles

Participant Flow:   Overall Study
    Pegylated Liposomal Doxorubicin
STARTED   167 
COMPLETED   56 
NOT COMPLETED   111 
Did Not Receive Drug or Not Documented                7 
Data Missing                2 
Tumor Progression                75 
Toxicity                6 
Withdrawal by Subject                10 
Death                7 
Not Specified                4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Pegylated Liposomal Doxorubicin Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles

Baseline Measures
   Pegylated Liposomal Doxorubicin 
Overall Participants Analyzed 
[Units: Participants]
 160 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 62  (12) 
[1] Age was calculated for the intent-to-treat (ITT) population only (those who received at least one dose of study medication).
Gender [1] 
[Units: Participants]
 
Female   159 
Male   1 
[1] Gender information was available only for the ITT population.


  Outcome Measures
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1.  Primary:   Number of Participants With Infusion Reactions (IR)   [ Time Frame: Day 1 up to Week 24 ]

2.  Primary:   Percent of Participants Taking Premedication for Prevention of IR   [ Time Frame: Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin ]

3.  Primary:   Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR   [ Time Frame: Cycles 1 & 3 (Week 4 & Week 12) ]

4.  Primary:   Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE)   [ Time Frame: Up to 24 weeks ]

5.  Primary:   Number of Times Premedications Were Given for Prevention of PPE   [ Time Frame: Day 1 up to 24 weeks ]

6.  Secondary:   Number of Participants With Complete Response (CR) or Partial Response (PR)   [ Time Frame: Day 1 up to 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Cllinical Development
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00736333     History of Changes
Other Study ID Numbers: P04878
Study First Received: July 25, 2008
Results First Received: June 13, 2011
Last Updated: October 31, 2014
Health Authority: Austria: Ethikkommission