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A Study of Docetaxel Monotherapy or DOXIL and Docetaxel in Patients With Advanced Breast Cancer

This study has been completed.
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Identifier:
First received: September 8, 2004
Last updated: April 2, 2014
Last verified: April 2014
Results First Received: December 15, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Docetaxel

  Participant Flow

  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
Docetaxel Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
DOXIL+Docetaxel DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
Total Total of all reporting groups

Baseline Measures
   Docetaxel   DOXIL+Docetaxel   Total 
Overall Participants Analyzed 
[Units: Participants]
 373   378   751 
[Units: Years]
Mean (Standard Deviation)
 52.0  (9.23)   52.8  (9.17)   52.4  (9.20) 
[Units: Participants]
Female   373   378   751 
Male   0   0   0 

  Outcome Measures
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1.  Primary:   Time to Progression   [ Time Frame: From date of randomization until date of disease progression or death, whichever occurred first, until approximately 485 events of disease progression or death were observed, as assessed approximately 15 months after the last patient was enrolled ]

2.  Secondary:   Overall Survival   [ Time Frame: From the date of randomization until the participant's death from any cause, as assessed until approximately 485 death events were observed which is assessed approximately 25 months after the last patient was enrolled ]

3.  Secondary:   Response Rate: Number of Participants in the Evaluable Population Who Achieved a Complete Response (CR) or Partial Response (PR)   [ Time Frame: Up to 30 to 42 days after last dose of study medication ]

  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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