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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 (BOLERO-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00863655
First received: March 16, 2009
Last updated: March 21, 2017
Last verified: March 2017
Results First Received: July 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Everolimus
Drug: Exemestane
Drug: Everolimus Placebo

  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
Although 724 patients were randomized, 4 never received any study treatment and thus were excluded form the safety set.

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   0 [1]   0 [1] 
NOT COMPLETED   485   239 
Protocol Violation                4                0 
Adverse Event                52                8 
Withdrawal by Subject                47                7 
Administrative problems                1                0 
Death                7                1 
New cancer therapy                5                1 
Disease progression                364                221 
Treatment completed as per protocol                5                1 
[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.
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
Total Total of all reporting groups

Baseline Measures
   Everolimus + Exemestane   Placebo + Exemestane   Total 
Overall Participants Analyzed 
[Units: Participants]
 485   239   724 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.5  (10.31)   61.2  (9.75)   62.1  (10.14) 
Age, Customized 
[Units: Participants]
     
< 65 years   290   159   449 
>= 65 years   195   80   275 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      485 100.0%      239 100.0%      724 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All 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 up to about 19 months ]

2.  Secondary:   Overall Survival (OS) by Number of Deaths   [ Time Frame: up to 53 months ]

3.  Secondary:   Overall Survival (OS) by Median   [ Time Frame: up to 53 months ]

4.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: up to 21 months ]

5.  Secondary:   Clinical Benefit Rate (CBR)   [ Time Frame: up to 21 months ]

6.  Secondary:   Proportion of Patients With no Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Using Kaplan-Meier   [ Time Frame: 2, 4, 6, 9 months ]

7.  Secondary:   Patient-reported Outcomes (PROs): Time to Deterioration of PRO Scores Using Kaplan Meier - EORTC QLQ-C30   [ Time Frame: Up to 21 months ]

8.  Secondary:   Proportion of Patients With Having no Overall Response Based on Investigator Assessment   [ Time Frame: 2, 4, 6, 9 months ]

9.  Secondary:   Duration of Response (Among Participants With Best Overall Response of CR or PR) Estimated Per Kaplan-Meier   [ Time Frame: 21 months ]

10.  Secondary:   Everolimus Concentrations at Week 4   [ Time Frame: pre-dose, 2 hours post-dose ]

11.  Secondary:   Exemestane Concentrations at Week 4   [ Time Frame: predose, 2 hours post-dose ]

12.  Secondary:   Estradiol Plasma Concentrations   [ Time Frame: Baseline, Week 4 ]


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


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


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00863655     History of Changes
Other Study ID Numbers: CRAD001Y2301
2008-008698-69 ( EudraCT Number )
Study First Received: March 16, 2009
Results First Received: July 31, 2012
Last Updated: March 21, 2017