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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00091442
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;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Docetaxel
Drug: DOXIL

  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
  Description
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
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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
  Description
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 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.0  (9.23)   52.8  (9.17)   52.4  (9.20) 
Gender 
[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
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Time Frame From first dose of study medication until 30 days after the last dose of study medication.
Additional Description 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.

Frequency Threshold
Threshold above which other adverse events are reported   5  

Reporting Groups
  Description
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.

Other Adverse Events
    Docetaxel   DOXIL+Docetaxel
Total, other (not including serious) adverse events     
# participants affected / at risk   340/373 (91.15%)   359/377 (95.23%) 
Blood and lymphatic system disorders     
Anaemia † 1     
# participants affected / at risk   62/373 (16.62%)   75/377 (19.89%) 
Febrile neutropenia † 1     
# participants affected / at risk   14/373 (3.75%)   19/377 (5.04%) 
Leukopenia † 1     
# participants affected / at risk   99/373 (26.54%)   126/377 (33.42%) 
Neutropenia † 1     
# participants affected / at risk   241/373 (64.61%)   244/377 (64.72%) 
Cardiac disorders     
Tachycardia † 1     
# participants affected / at risk   14/373 (3.75%)   21/377 (5.57%) 
Gastrointestinal disorders     
Constipation † 1     
# participants affected / at risk   18/373 (4.83%)   13/377 (3.45%) 
Diarrhoea † 1     
# participants affected / at risk   42/373 (11.26%)   56/377 (14.85%) 
Mucositis/stomatitis † 1     
# participants affected / at risk   53/373 (14.21%)   195/377 (51.72%) 
Nausea † 1     
# participants affected / at risk   80/373 (21.45%)   105/377 (27.85%) 
Vomiting † 1     
# participants affected / at risk   35/373 (9.38%)   38/377 (10.08%) 
General disorders     
Asthenia † 1     
# participants affected / at risk   72/373 (19.30%)   110/377 (29.18%) 
Fatigue † 1     
# participants affected / at risk   56/373 (15.01%)   78/377 (20.69%) 
Oedema peripheral † 1     
# participants affected / at risk   34/373 (9.12%)   17/377 (4.51%) 
Pyrexia † 1     
# participants affected / at risk   31/373 (8.31%)   59/377 (15.65%) 
Infections and infestations     
Respiratory tract infection † 1     
# participants affected / at risk   12/373 (3.22%)   21/377 (5.57%) 
Investigations     
Alanine aminotransferase increased † 1     
# participants affected / at risk   29/373 (7.77%)   31/377 (8.22%) 
Aspartate aminotransferase increased † 1     
# participants affected / at risk   31/373 (8.31%)   26/377 (6.90%) 
Weight decreased † 1     
# participants affected / at risk   6/373 (1.61%)   18/377 (4.77%) 
Metabolism and nutrition disorders     
Anorexia † 1     
# participants affected / at risk   21/373 (5.63%)   33/377 (8.75%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1     
# participants affected / at risk   25/373 (6.70%)   26/377 (6.90%) 
Bone pain † 1     
# participants affected / at risk   26/373 (6.97%)   12/377 (3.18%) 
Myalgia † 1     
# participants affected / at risk   33/373 (8.85%)   32/377 (8.49%) 
Nervous system disorders     
Dizziness † 1     
# participants affected / at risk   12/373 (3.22%)   18/377 (4.77%) 
Dysgeusia † 1     
# participants affected / at risk   22/373 (5.90%)   10/377 (2.65%) 
Headache † 1     
# participants affected / at risk   21/373 (5.63%)   39/377 (10.34%) 
Peripheral neuropathy † 1     
# participants affected / at risk   68/373 (18.23%)   78/377 (20.69%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1     
# participants affected / at risk   23/373 (6.17%)   23/377 (6.10%) 
Dyspnoea † 1     
# participants affected / at risk   40/373 (10.72%)   29/377 (7.69%) 
Skin and subcutaneous tissue disorders     
Alopecia † 1     
# participants affected / at risk   169/373 (45.31%)   181/377 (48.01%) 
Erythema † 1     
# participants affected / at risk   6/373 (1.61%)   17/377 (4.51%) 
Nail disorder † 1     
# participants affected / at risk   26/373 (6.97%)   37/377 (9.81%) 
Palmar-plantar erythrodysaesthesia syndrome † 1     
# participants affected / at risk   5/373 (1.34%)   229/377 (60.74%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 10.0



  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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