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: March 21, 2013
Last verified: March 2013
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.
No text entered.

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  
Number of Participants  
[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     359/377  
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%)  
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%)  
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%)  
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%)  
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%)  
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%)  
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%)  
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%)  
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%)  
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%)  
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%)  
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



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Director Medical Leader
Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
phone: 908 218 7361 ext NA


No publications provided


Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00091442     History of Changes
Obsolete Identifiers: NCT00343538
Other Study ID Numbers: CR004120, DOXILBCA3001
Study First Received: September 8, 2004
Results First Received: December 15, 2009
Last Updated: March 21, 2013
Health Authority: United States: Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health