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Open-label, Phase II Study of Stomatitis Prevention With a Steroid-based Mouthwash in Post-menopausal Women With Estrogen-receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)- Metastatic or Locally Advanced Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT02069093
First received: February 20, 2014
Last updated: December 20, 2016
Last verified: December 2016
Results First Received: October 19, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Advanced Breast Cancer
Interventions: Drug: Dexamethasone based mouthwash
Drug: Everolimus
Drug: Exemestane

  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
A total of 92 participants were enrolled into the study and received study treatments of everolimus and exemestane. Of these, 86 participants were confirmed to have also received the investigational treatment of dexamethasone steroid mouthwash and comprised the full analysis set (FAS). The patient disposition is based on the FAS.

Reporting Groups
  Description
Dexamethasone Based Mouthwash Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.

Participant Flow:   Overall Study
    Dexamethasone Based Mouthwash
STARTED   86 
Pharmacokinetic Analysis Set   50 
COMPLETED   56 
NOT COMPLETED   30 
Disease progression                14 
New cancer therapy                1 
Death                1 
Administrative problems                1 
Withdrawal by Subject                2 
Abnormal laboratory values                1 
Adverse Event                10 



  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.
Full analysis set: The full analysis set consisted of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash).

Reporting Groups
  Description
Dexamethasone Based Mouthwash Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.

Baseline Measures
   Dexamethasone Based Mouthwash 
Overall Participants Analyzed 
[Units: Participants]
 86 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.02  (10.921) 
Gender, Customized 
[Units: Participants]
 
Female   86 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Stomatitis Grade ≥ 2   [ Time Frame: 56 days ]

2.  Secondary:   Time to Resolution of Stomatitis From Grade 2 or Greater to Grade 1 or Less   [ Time Frame: 56 days ]

3.  Secondary:   Median Number of Mouthwashes Per Day   [ Time Frame: 56 days ]

4.  Secondary:   Number of Participants With All Grades of Stomatitis   [ Time Frame: 56 days ]

5.  Secondary:   Dose Intensity of Everolimus and Exemestane   [ Time Frame: 56 days ]

6.  Secondary:   Blood Concentration of Everolimus and Exemestane   [ Time Frame: 28 days (pre-dose) ]


  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: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02069093     History of Changes
Other Study ID Numbers: CRAD001JUS226
Study First Received: February 20, 2014
Results First Received: October 19, 2016
Last Updated: December 20, 2016