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A Study Of Everolimus, Trastuzumab And Vinorelbine In HER2-Positive Breast Cancer Brain Metastases

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01305941
First Posted: March 1, 2011
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
Results First Submitted: July 28, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HER-2 Positive Breast Cancer
Interventions: Drug: Everolimus
Drug: Vinorelbine
Drug: Trastuzumab

  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
Subjects were recruited from 4 institutions between September, 2011 and May, 2016.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 41 patients were consented to this study. Of these, 6 patients were found ineligible, 2 withdrew prior to treatment, and 1 patient has disease progression prior to protocol therapy. Therefore only 32 patients were enrolled and participated in the trial.

Reporting Groups
  Description
Everolimus +Vinorelbine + Trastuzumab

daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab

Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets

Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.

Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly


Participant Flow:   Overall Study
    Everolimus +Vinorelbine + Trastuzumab
STARTED   32 
COMPLETED   22 
NOT COMPLETED   10 
Adverse Event                6 
Clinical decline                2 
Withdrawal by Subject                1 
Death                1 



  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.
No text entered.

Reporting Groups
  Description
Everolimus +Vinorelbine + Trastuzumab

daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab

Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets

Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.

Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly


Baseline Measures
   Everolimus +Vinorelbine + Trastuzumab 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age 
[Units: Years]
Median (Full Range)
 53 
 (28 to 70) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      32 100.0% 
Male      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   3.1% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      4  12.5% 
White      26  81.3% 
More than one race      0   0.0% 
Unknown or Not Reported      1   3.1% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   32 
Stage at breast cancer diagnosis [1] 
[Units: Participants]
Count of Participants
 
0-III      19  59.4% 
IV      13  40.6% 
[1]

Anatomic stage for NSCLC is the American Joint Committee on Cancer (AJCC) tumor, node, and metastases (TNM) system, which is based on:

Size of primary tumor (T) and whether it has grown into nearby areas. Spread to regional lymph nodes (N). Spread (metastasis; M) to other organs of the body. Once the T, N, and M categories have been determined, this information is combined into a prognostic group. Higher numbers mean the cancer is more advanced.

Median time since first brain metastases (years) 
[Units: Years]
Median (Full Range)
 1.12 
 (0.4 to 6.5) 
Prior Systemic Chemotherapy (metastatic) [1] 
[Units: Participants]
Count of Participants
 30 
[1] Number of participants who received prior systemic chemotherapy.
Prior metastatic chemotherapy lines, # (range) 
[Units: Metastatic Lines]
Median (Full Range)
 2 
 (0 to 7) 
Prior anti-Her2 (metastatic) Agents 
[Units: Participants]
Count of Participants
 
Trastuzumab   29 
Lapatinib   22 
Pertuzumab   12 
Trastuzumab Emtansine (TDM-1)   8 
Prior Central Nervous System Local Therapy 
[Units: Participants]
Count of Participants
 
Surgery   10 
Whole brain radiation therapy   22 
Stereotactic Radiosurgery (SRS)   17 
Recursive Partitioning Analysis (RPA) Score [1] 
[Units: Participants]
Count of Participants
 
Class 1      10  31.3% 
Class 2      21  65.6% 
Class 3      1   3.1% 
[1]

Recursive partitioning creates a decision tree that classifies members of a population by splitting it into sub-populations based on several dichotomous independent variables. The process is termed recursive because each sub-population may in turn be split an indefinite number of times.

This includes three classes: Class 1 (patients <65 years, ECOG Performance Status of 0-1, controlled primary tumor, and no extracranial metastases), Class 3 (ECOG Performance Status of 2 or greater), and Class 2 (all others);

Steroid use at baseline [1] 
[Units: Participants]
Count of Participants
 10 
[1] Treatment with corticosteroid drugs to reduce swelling, pain, and other symptoms of inflammation.
Extracranial disease at enrollment [1] 
[Units: Participants]
Count of Participants
 20 
[1] Outside of the cranium (bones that surround the brain).


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Intracranial Objective Response Rate- Modified RECIST Criteria   [ Time Frame: 3 years ]

2.  Secondary:   Intracranial Response Rate- MacDonald Criteria   [ Time Frame: 3 years ]

3.  Secondary:   Toxicity   [ Time Frame: 24 weeks ]

4.  Secondary:   Time to Intracranial Progression.   [ Time Frame: 3 years ]

5.  Secondary:   Extracranial Response   [ Time Frame: 3 years ]

6.  Secondary:   Extracranial Time to Progression   [ Time Frame: 3 years ]

7.  Secondary:   Overall Survival   [ Time Frame: 3 years ]

8.  Secondary:   Functional Assessment of Cancer Therapy- Brain (FACT-Br) Change From Baseline to Assess Impact of Everolimus in Combination With Trastuzumab and Vinorelbine on Quality of Life   [ Time Frame: 9 weeks ]

9.  Secondary:   Functional Assessment Cancer Therapy- Breast (FACT-B) From Baseline to 9 Weeks of Treatment to Assess Impact of Everolimus in Combination With Trastuzumab and Vinorelbine on Quality of Life   [ Time Frame: 9 weeks ]


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Robin V. Johnson
Organization: UNC Comprehensive Cancer Center
phone: 919-966-1125
e-mail: Robin_V_Johnson@med.unc.edu



Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01305941     History of Changes
Other Study ID Numbers: LCCC 1025
11-0242 ( Other Identifier: UNC IRB assigned protocol number )
First Submitted: February 25, 2011
First Posted: March 1, 2011
Results First Submitted: July 28, 2017
Results First Posted: October 17, 2017
Last Update Posted: October 17, 2017