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The Efficacy and Safety of Pegylated Liposomal Doxorubicin Compared With Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer (P04445/MK-2746-071)

This study has been completed.
Sponsor:
Collaborator:
Essex Pharma GmbH
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00266799
First received: December 15, 2005
Last updated: November 3, 2014
Last verified: November 2014
Results First Received: October 10, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Pegylated liposomal doxorubicin (SCH 200746)
Drug: Capecitabine

  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
210 participants were enrolled with 105 participants randomized for treatment with PLD and 105 participants randomized for treatment with Capecitabine, of which 7 participants in the PLD group and 3 participants in the Capecitabine group were not treated.

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 (PLD) PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
Capecitabine Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.

Participant Flow:   Overall Study
    Pegylated Liposomal Doxorubicin (PLD)     Capecitabine  
STARTED     98     102  
COMPLETED     62     68  
NOT COMPLETED     36     34  



  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.
No text entered.

Reporting Groups
  Description
Pegylated Liposomal Doxorubicin (PLD) PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
Capecitabine Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
    Pegylated Liposomal Doxorubicin (PLD)     Capecitabine     Total  
Number of Participants  
[units: participants]
  105     105     210  
Age [1]
[units: years]
Mean ± Standard Deviation
  61.4  ± 10.66     61.5  ± 10.59     61.5  ± 10.60  
Gender [1]
[units: participants]
     
Female     105     105     210  
Male     0     0     0  
[1] For baseline characteristics, all 210 participants who were enrolled and randomized were incorporated , although 7 participants in the PLD group and 3 participants in the Capecitabine group were not treated.



  Outcome Measures
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1.  Primary:   Time to Disease Progression (TTP) Using Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death ]

2.  Secondary:   Number of Participants With an Overall Response (Complete Response [CR] + Partial Response [PR]) Between PLD and Capecitabine Treatment Groups   [ Time Frame: From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death ]

3.  Secondary:   Overall Survival Time in the PLD and Capecitabine Treatment Groups   [ Time Frame: From Day 1 (Cycle 1) until Death ]

4.  Secondary:   Time to Treatment Failure in the PLD and the Capecitabine Treatment Groups   [ Time Frame: From Day 1 (Cycle 1) until End of Treatment ]

5.  Secondary:   Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ))   [ Time Frame: From Screening to Day 1 of every Treatment Cycle up to 12 Cycles ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00266799     History of Changes
Other Study ID Numbers: P04445
Study First Received: December 15, 2005
Results First Received: October 10, 2011
Last Updated: November 3, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices