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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
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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
A total of 751 participants were enrolled and randomized at 143 sites in 19 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
751 participants were randomly assigned to 2 treatment groups (Docetaxel: 373 ; DOXIL+docetaxel: 378). 750 participants received treatment (Docetaxel: 373; DOXIL+docetaxel: 377). 1 participant in DOXIL+docetaxel treatment group did not receive treatment.

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.

Participant Flow:   Overall Study
    Docetaxel   DOXIL+Docetaxel
STARTED   373   378 
COMPLETED   4 [1]   5 [1] 
NOT COMPLETED   369   373 
Progressive Disease                220                189 
Physician Decision                61                58 
Withdrawal by Subject                38                46 
Adverse Event                29                48 
2cycles therapy beyond Complete response                9                16 
Death                9                7 
Lost to Follow-up                1                3 
Not Specified                2                6 
[1] Indicates number of participants on study treatment at time of the primary objective

  Baseline Characteristics

  Outcome Measures
  Show All Outcome Measures

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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