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 (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00687440
First received: May 27, 2008
Last updated: April 25, 2014
Last verified: April 2014
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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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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
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]
  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. ]


  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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
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: April 25, 2014
Health Authority: Italy: Ministry of Health