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Trial record 1 of 1 for:    NCT01491737
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A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer (PERTAIN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01491737
First received: December 6, 2011
Last updated: August 9, 2017
Last verified: August 2017
Results First Received: May 11, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Pertuzumab
Drug: Trastuzumab
Drug: Aromatase Inhibitor
Drug: Induction Chemotherapy

  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
A total of 258 participants were enrolled in the study from 17 February 2012. Results are presented here up to data cut-off date (17 March 2016).

Reporting Groups
  Description
Arm A: Pertuzumab and Trastuzumab Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
Arm B: Trastuzumab Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.

Participant Flow:   Overall Study
    Arm A: Pertuzumab and Trastuzumab   Arm B: Trastuzumab
STARTED   129   129 
COMPLETED   80   79 
NOT COMPLETED   49   50 
Withdrawal of consent                13                13 
Lost to Follow-up                1                6 
Death                33                28 
Reason not specified                2                3 



  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.
Intent to treat (ITT) included all randomized participants.

Reporting Groups
  Description
Arm A: Pertuzumab and Trastuzumab Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
Arm B: Trastuzumab Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
Total Total of all reporting groups

Baseline Measures
   Arm A: Pertuzumab and Trastuzumab   Arm B: Trastuzumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 129   129   258 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.9  (10.85)   62.3  (11.54)   61.6  (11.20) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      129 100.0%      129 100.0%      258 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: Baseline to progressive disease or death (approximately, up to 49 months) ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: From the date of randomization until first documented death (approximately, up to 49 months) ]

3.  Secondary:   Duration of Response (DOR)   [ Time Frame: Baseline up to 49 months, approximately ]

4.  Secondary:   Time to Response (TTR)   [ Time Frame: Baseline up to 49 months, approximately ]

5.  Secondary:   Objective Overall Response Rate (ORR)   [ Time Frame: Baseline up to 49 months, approximately ]

6.  Secondary:   Clinical Benefit Response (CBR)   [ Time Frame: Baseline up to 49 months, approximately ]

7.  Secondary:   Change From Baseline in Health-Related Quality of Life as Determined by European Quality of Life 5-Dimension (EQ-5D) Visual Analog Scale (VAS) Scores   [ Time Frame: Baseline, every 3 cycles (21-day cycle), and every 3 months after treatment discontinuation (up to 49 months, approximately) ]

8.  Secondary:   Percentage of Participants With Any Adverse Event (AE)   [ Time Frame: Up to 49 months approximately ]


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01491737     History of Changes
Other Study ID Numbers: MO27775
2011-002132-10 ( EudraCT Number )
Study First Received: December 6, 2011
Results First Received: May 11, 2017
Last Updated: August 9, 2017