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:
Genentech, Inc.
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00567190
First received: December 3, 2007
Last updated: January 22, 2014
Last verified: January 2014
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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
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 |
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| 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
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
Show All Outcome Measures
| 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) ] |
Hide Outcome Measure 4
| 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) ] |
Hide Outcome Measure 5
| 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) ] |
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 |
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| The survival data at the time of the data cut-off were not mature. |