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A Study to Determine the Activity of Caelyx With Trastuzumab and Docetaxel in the Treatment of Metastatic Breast Cancer (Study P03679)(COMPLETED)

This study has been completed.
Sponsor:
Collaborator:
MDS Pharma Services
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00687440
First received: May 27, 2008
Last updated: February 24, 2010
Last verified: February 2010
History of Changes
Results First Received: January 21, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Neoplasm
Interventions: Drug: Pegylated Liposomal Doxorubicin
Drug: Docetaxel
Drug: Trastuzumab

  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
Caelyx, Docetaxel, Trastuzumab

Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.

Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab.

Participant Flow:   Overall Study
    Caelyx, Docetaxel, Trastuzumab  
STARTED     27 [1]
COMPLETED     15  
NOT COMPLETED     12  
Adverse Event                 3  
Lost to Follow-up                 3  
Lack of Efficacy                 2  
Death                 2  
Not specified                 1  
Missing                 1  
[1] Number of screened participants



  Baseline Characteristics
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Reporting Groups
  Description
Caelyx, Docetaxel, Trastuzumab

Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.

Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab.

Baseline Measures
    Caelyx, Docetaxel, Trastuzumab  
Number of Participants  
[units: participants]
 		  27  
Age, Customized  
[units: years]
 		 
18 to 70     27  
Gender  
[units: participants]
 		 
Female     27  
Male     0  
Region of Enrollment  
[units: participants]
 		 
Italy     27  



  Outcome Measures

1.  Primary:   Number of Participants Who Had a Tumor Response, According to Standard RECIST (Response Evaluation Criteria in Solid Tumors) Criteria   [ Time Frame: Week 09, Week 18, at the end of each patient's treatment, and at 3, 6, 9, and 12 months after end of treatment. ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Head, Clinical Trials Registry & Results Dislcosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided


Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00687440     History of Changes
Other Study ID Numbers: P03679, Eudract No. 2004-003989-15
Study First Received: May 27, 2008
Results First Received: January 21, 2010
Last Updated: February 24, 2010
Health Authority: Italy: Ministry of Health