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, Inc.

ClinicalTrials.gov Identifier:

NCT00567190

First received: December 3, 2007

Last updated: March 21, 2017

Last verified: March 2017

History of Changes

Results First Received: August 14, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Participant, 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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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
Overall Participants Analyzed [Units: Participants]	402	406	808

Age [Units: Years] Mean (Standard Deviation)	53.4 (10.94)	53.5 (11.35)	53.5 (11.14)

Sex: Female, Male [Units: Participants] Count of Participants
Female	402 100.0%	404 99.5%	806 99.8%
Male	0 0.0%	2 0.5%	2 0.2%

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) ]

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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) ]

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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) ]

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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) ]

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Measure Type	Secondary
Measure Title	Objective Response Determined by an Independent Review Facility
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 primary data cut-off on 13 May 2011 (up to 3 years, 3 months)

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
Participants Analyzed [Units: Participants]	343	336
Objective Response Determined by an Independent Review Facility [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 Determined by an Independent Review Facility

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) ]

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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)

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
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) ]

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Serious Adverse Events

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Other Adverse Events

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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
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