A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer (CLEOPATRA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00567190
First received: December 3, 2007
Last updated: January 22, 2014
Last verified: January 2014
Results First Received: August 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Interventions: Drug: Pertuzumab
Drug: Placebo
Drug: Trastuzumab
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
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
Pertuzumab + Trastuzumab + Docetaxel Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
Placebo + Trastuzumab + Docetaxel Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.

Participant Flow:   Overall Study
    Pertuzumab + Trastuzumab + Docetaxel     Placebo + Trastuzumab + Docetaxel  
STARTED     402     406  
COMPLETED     315     287  
NOT COMPLETED     87     119  
Death                 69                 96  
Withdrew Consent                 12                 18  
Lost to Follow-up                 6                 5  



  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
Pertuzumab + Trastuzumab + Docetaxel Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
Placebo + Trastuzumab + Docetaxel Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
Total Total of all reporting groups

Baseline Measures
    Pertuzumab + Trastuzumab + Docetaxel     Placebo + Trastuzumab + Docetaxel     Total  
Number of Participants  
[units: participants]
  402     406     808  
Age  
[units: years]
Mean ± Standard Deviation
  53.4  ± 10.94     53.5  ± 11.35     53.5  ± 11.14  
Gender  
[units: participants]
     
Female     402     404     806  
Male     0     2     2  



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS) Determined by an Independent Review Facility   [ Time Frame: Baseline to data cut-off (up to 3 years, 3 months) ]

2.  Secondary:   Overall Survival   [ Time Frame: Baseline to data cut-off (up to 3 years, 3 months) ]

3.  Secondary:   Progression-free Survival (PFS) Determined by the Investigator   [ Time Frame: Baseline to data cut-off (up to 3 years, 3 months) ]

4.  Secondary:   Objective Response   [ Time Frame: Baseline to data cut-off (up to 3 years, 3 months) ]
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Measure Type Secondary
Measure Title Objective Response
Measure Description A patient had an objective response if they had a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart as determined by the investigator using RECIST. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.
Time Frame Baseline to data cut-off (up to 3 years, 3 months)  
Safety Issue No  

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.
Intent-to-treat population: All randomized patients. Only patients with measurable disease at baseline were included in the analysis.

Reporting Groups
  Description
Pertuzumab + Trastuzumab + Docetaxel Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
Placebo + Trastuzumab + Docetaxel Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.

Measured Values
    Pertuzumab + Trastuzumab + Docetaxel     Placebo + Trastuzumab + Docetaxel  
Number of Participants Analyzed  
[units: participants]
  343     336  
Objective Response  
[units: Percentage¬†of¬†patients]
Number ( 95% Confidence Interval )
  80.2  
  ( 75.6 to 84.3 )  
  69.3  
  ( 64.1 to 74.2 )  

No statistical analysis provided for Objective Response



5.  Secondary:   Duration of Objective Response   [ Time Frame: Baseline to data cut-off (up to 3 years, 3 months) ]
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Measure Type Secondary
Measure Title Duration of Objective Response
Measure Description Duration of objective response was defined as the time from the initial response to documented disease progression or death from any cause, whichever occurred first.
Time Frame Baseline to data cut-off (up to 3 years, 3 months)  
Safety Issue No  

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.
Intent-to-treat population: All randomized patients. Only patients with an objective response were included in the analysis.

Reporting Groups
  Description
Pertuzumab + Trastuzumab + Docetaxel Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
Placebo + Trastuzumab + Docetaxel Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.

Measured Values
    Pertuzumab + Trastuzumab + Docetaxel     Placebo + Trastuzumab + Docetaxel  
Number of Participants Analyzed  
[units: participants]
  275     233  
Duration of Objective Response  
[units: Weeks]
Median ( 95% Confidence Interval )
  87.6  
  ( 71.0 to 106.0 )  
  54.1  
  ( 46.0 to 64.0 )  

No statistical analysis provided for Duration of Objective Response



6.  Secondary:   Time to Symptom Progression   [ Time Frame: Baseline to data cut-off (up to 3 years, 3 months) ]


  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
The survival data at the time of the data cut-off were not mature.


  More Information