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


  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) ]

5.  Secondary:   Duration of Objective Response   [ Time Frame: Baseline to data cut-off (up to 3 years, 3 months) ]

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.


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