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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00687440
First Posted: May 30, 2008
Last Update Posted: June 8, 2017
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.
Collaborator:
MDS Pharma Services
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: January 21, 2010  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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 
Overall Participants Analyzed 
[Units: Participants]
 27 
Age, Customized 
[Units: Years]
 27 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      27 100.0% 
Male      0   0.0% 
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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00687440     History of Changes
Other Study ID Numbers: P03679
Eudract No. 2004-003989-15
First Submitted: May 27, 2008
First Posted: May 30, 2008
Results First Submitted: January 21, 2010
Results First Posted: February 15, 2010
Last Update Posted: June 8, 2017