Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole (BOLERO2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00863655
First received: March 16, 2009
Last updated: October 18, 2013
Last verified: October 2013
Results First Received: July 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Everolimus
Drug: Placebo
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
No text entered.

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
Everolimus + Exemestane Everolimus 10 mg daily in combination with exemestane 25 mg daily
Placebo + Exemestane Placebo of everolimus in combination with exemestane 25 mg daily

Participant Flow:   Overall Study
    Everolimus + Exemestane     Placebo + Exemestane  
STARTED     485     239  
COMPLETED     258 [1]   170 [1]
NOT COMPLETED     227     69  
Ongoing                 227                 69  
[1] Completed means discontinued the treatment period.



  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.
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Reporting Groups
  Description
Everolimus + Exemestane Everolimus 10 mg daily in combination with exemestane 25 mg daily
Placebo + Exemestane Placebo of everolimus in combination with exemestane 25 mg daily
Total Total of all reporting groups

Baseline Measures
    Everolimus + Exemestane     Placebo + Exemestane     Total  
Number of Participants  
[units: participants]
  485     239     724  
Age  
[units: years]
Mean ± Standard Deviation
  62.5  ± 10.31     61.2  ± 9.75     62.1  ± 10.14  
Gender  
[units: participants]
     
Female     485     239     724  
Male     0     0     0  



  Outcome Measures

1.  Primary:   Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments.   [ Time Frame: date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first ,reported between day of first patient randomized, 27 July 2009, until cut-off date 11 February 2011. ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Every 3 months after End of Treatment + 28 days (every 6 weeks before) ]
Results not yet posted.   Anticipated Posting Date:   02/2014   Safety Issue:   No

3.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: Every 6 weeks ]
Results not yet posted.   Anticipated Posting Date:   02/2014   Safety Issue:   No

4.  Secondary:   Incidence of Adverse Events (AEs)/Serious Adverse Events (SAEs)   [ Time Frame: Continuous and every 6 weeks ]
Results not yet posted.   Anticipated Posting Date:   02/2014   Safety Issue:   Yes

5.  Secondary:   Qol Scores ECOG Performance Status   [ Time Frame: Every 6 weeks ]
Results not yet posted.   Anticipated Posting Date:   02/2014   Safety Issue:   Yes

6.  Secondary:   Clinical Benefit Rate (CBR)   [ Time Frame: Every 6 weeks ]
Results not yet posted.   Anticipated Posting Date:   02/2014   Safety Issue:   No


  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 Pharmaceutical
phone: 862-778-8300


No publications provided by Novartis

Publications automatically indexed to this study:


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00863655     History of Changes
Other Study ID Numbers: CRAD001Y2301, 2008-008698-69
Study First Received: March 16, 2009
Results First Received: July 31, 2012
Last Updated: October 18, 2013
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Brazil: National Health Surveillance Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Egypt: Ministry of Health, Drug Policy and Planning Center
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
Italy: National Institute of Health
Japan: Pharmaceuticals and Medical Devices Agency
Netherlands: Medicines Evaluation Board (MEB)
New Zealand: Food Safety Authority
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Thailand: Food and Drug Administration
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency