Safety/Efficacy of Letrozole Monotherapy or in Combination With Zoledronic Acid as Extended Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00332709
First received: May 31, 2006
Last updated: October 10, 2011
Last verified: October 2011
Results First Received: August 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Osteoporosis
Postmenopausal
Interventions: Drug: Letrozole
Drug: Zoledronic acid

  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
Total Randomized participants were 83. 2 patients were enrolled but never received study medication. Hence, 81 were included in the safety population.

Reporting Groups
  Description
Letrozole Letrozole 2.5 mg/day for 3 years
Letrozole + Zoledronic Acid Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months

Participant Flow:   Overall Study
    Letrozole     Letrozole + Zoledronic Acid  
STARTED     40     41  
COMPLETED     24     21  
NOT COMPLETED     16     20  
Adverse Event                 11                 14  
Withdrawal by Subject                 2                 3  
Lost to Follow-up                 2                 0  
Administrative Problems                 0                 3  
Abnormal test procedure result                 1                 0  



  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
Letrozole Letrozole 2.5 mg/day for 3 years
Letrozole + Zoledronic Acid Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
Total Total of all reporting groups

Baseline Measures
    Letrozole     Letrozole + Zoledronic Acid     Total  
Number of Participants  
[units: participants]
  37     39     76  
Age [1]
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     37     39     76  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  61.3  ± 7.3     58.4  ± 7.3     59.8  ± 7.4  
Gender  
[units: participants]
     
Female     37     39     76  
Male     0     0     0  
[1] Demographic data is provided for the Intent to Treat population.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Bone Mineral Density (BMD) From Baseline to Month 36   [ Time Frame: at 36 months as compared to baseline ]

2.  Primary:   Percent Change in Bone Mineral Density (BMD) From Baseline to Month 36   [ Time Frame: Baseline, Month 36 ]

3.  Primary:   Change in T-score From Baseline to Month 36   [ Time Frame: Baseline and Month 36 ]

4.  Primary:   Change in Z Score From Baseline to Month 36   [ Time Frame: Baseline, month 36 ]

5.  Secondary:   Change in Bone Mineral Density From Baseline to 12 Months   [ Time Frame: Baseline, 12 months ]

6.  Secondary:   Number of Participants With Any Kind of Fractures, by Visit.   [ Time Frame: Baseline, Month 6, 12, 18, 24 , 30 and 36 ]

7.  Secondary:   Median Disease Free Survival (DFS)   [ Time Frame: 36 months ]

8.  Secondary:   Change in T-Score From Baseline to Month 12   [ Time Frame: Baseline, Month 12 ]

9.  Secondary:   Change in Z-Score From Baseline to Month 12   [ Time Frame: Baseline, Month 12 ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00332709     History of Changes
Other Study ID Numbers: CFEM345DDE09
Study First Received: May 31, 2006
Results First Received: August 11, 2011
Last Updated: October 10, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices