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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00567190
First received: December 3, 2007
Last updated: April 6, 2016
Last verified: April 2016
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 [1]   406 [1]
COMPLETED     192 [2]   142 [3]
NOT COMPLETED     210     264  
Death                 168                 221  
Withdrew Consent or Lost to Follow-up                 42                 43  
[1] All randomized patients (Intent-to-Treat [ITT]) population
[2] On 11 February 2014, 67 were alive and on study treatment; 125 were alive and in survival follow-up
[3] On 11 February 2014, 37 were alive and on study treatment; 105 were alive and in survival follow-up



  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.
ITT population

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: Patients]
     
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 primary data cut-off on 13 May 2011 (up to 3 years, 3 months) ]

2.  Secondary:   Overall Survival   [ Time Frame: Baseline to the third data cut-off (11 February 2014) at 389 deaths (approximately 43 months after enrollment of the last patient, up to 6 years overall) ]

3.  Secondary:   Progression-free Survival (PFS) Determined by the Investigator   [ Time Frame: Baseline to the third data cut-off (11 February 2014) at 389 deaths (approximately 43 months after enrollment of the last patient, up to 6 years overall) ]

4.  Secondary:   Objective Response Determined by an Independent Review Facility   [ Time Frame: Baseline to primary data cut-off on 13 May 2011 (up to 3 years, 3 months) ]

5.  Secondary:   Duration of Objective Response Determined by an Independent Review Facility   [ Time Frame: Baseline to primary data cut-off on 13 May 2011 (up to 3 years, 3 months) ]
  Hide Outcome Measure 5

Measure Type Secondary
Measure Title Duration of Objective Response Determined by an Independent Review Facility
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 primary data cut-off on 13 May 2011 (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 Determined by an Independent Review Facility  
[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 Determined by an Independent Review Facility



6.  Secondary:   Time to Symptom Progression   [ Time Frame: Baseline to primary data cut-off on 13 May 2011 (up to 3 years, 3 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information