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Use of PRO Onc Assay to Assess HER2 in Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Prometheus Laboratories
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT01048099
First received: January 12, 2010
Last updated: December 22, 2015
Last verified: December 2015
Results First Received: October 8, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Procedure: PRO Onc Assay and Treatment
Drug: Trastuzumab
Drug: Pertuzumab

  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
Pts with HER2-negative, metastatic breast cancer were enrolled. Blood was collected to perform the PRO Onc Circulating Tumor Cell (CTC). Pts without CTCs present were taken off-study. Following the assay, pts without detected HER2 overexpression/activation were taken off-study. Of the remaining pts, those FISH-positive for HER2 came off-study.

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
All Patients No text entered.

Participant Flow for 4 periods

Period 1:   Patients Enrolled and Blood Collected
    All Patients  
STARTED     283 [1]
COMPLETED     226 [2]
NOT COMPLETED     57  
Patients without circulating tumor cells                 57  
[1] Patients enrolled
[2] Patients with circulating tumor cells (CTCs)

Period 2:   Patients Evaluated by PRO Onc Assay
    All Patients  
STARTED     226 [1]
COMPLETED     24 [2]
NOT COMPLETED     202  
Patients with no HER2 abnormality                 202  
[1] Patients with CTCs who were evaluated by PRO Onc Assay
[2] Patients evaluated by PRO Onc Assay with HER2 overexpression/activation detected

Period 3:   Pts w/ HER2 Overexpression/Activation
    All Patients  
STARTED     24 [1]
COMPLETED     14 [2]
NOT COMPLETED     10  
[1] Patients with detected HER2 activation and/or overexpression
[2] Patients who proceeded to treatment

Period 4:   Treatment Per Protocol
    All Patients  
STARTED     14  
COMPLETED     0 [1]
NOT COMPLETED     14  
[1] Patients continued treatment until disease progression or coming off-study for any other reason



  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.
Excludes patients with no circulating tumor cells for the PRO Onc Assay

Reporting Groups
  Description
Patients Treated Patients who received study treatment

Baseline Measures
    Patients Treated  
Number of Participants  
[units: participants]
  14  
Age  
[units: years]
Median (Full Range)
  65  
  (47 to 83)  
Gender  
[units: participants]
 
Female     14  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     14  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Part II: Objective Response Rate of HER2-negative Metastatic Breast Cancer (by FISH Testing)   [ Time Frame: 18 months ]

2.  Primary:   Part II: Objective Response Rate of Trastuzumab Therapy   [ Time Frame: 18 months ]

3.  Primary:   Part II: Objective Response Rate of Pertuzumab Therapy   [ Time Frame: 18 months ]

4.  Secondary:   Part 1: The Incidence of HER2 Overexpression/Activation as Measured by the PRO Onc Assay   [ Time Frame: 12 months ]

5.  Secondary:   Part I: The Incidence of Isolation of Circulating Tumor Cells (CTCs) From Blood Specimens   [ Time Frame: 12 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
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  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: John D. Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-691-7274
e-mail: asksarah@scresearch.net


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01048099     History of Changes
Other Study ID Numbers: SCRI BRE 166
Study First Received: January 12, 2010
Results First Received: October 8, 2015
Last Updated: December 22, 2015
Health Authority: United States: Food and Drug Administration