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Trial record 1 of 2 for:    Extended Endocrine Therapy for Premenopausal Women With Breast Cancer
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Extended Endocrine Therapy for Premenopausal Women With Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Novartis
Information provided by (Responsible Party):
Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00903162
First received: May 5, 2009
Last updated: March 18, 2016
Last verified: January 2016
Results First Received: June 19, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: leuprolide
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
Potential patients were approached in the Dana-Farber Breast Oncology clinic and Newton Wellesley Hospital. Eligible patients were then presented with the study and given an opportunity to sign consent. The recruitment period ran from March 30th 2009 to May 1st, 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 17 patients were enrolled in this study; however, only 16 patients started treatment. One patient withdrew from the study before starting treatment.

Reporting Groups
  Description
Letrozole-Leuprolide

Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.

leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years

letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration

zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)


Participant Flow:   Overall Study
    Letrozole-Leuprolide
STARTED   16 
COMPLETED   12 
NOT COMPLETED   4 



  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.
Enrolled participants.

Reporting Groups
  Description
Letrozole-Leuprolide

Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.

leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years

letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration

zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)


Baseline Measures
   Letrozole-Leuprolide 
Overall Participants Analyzed 
[Units: Participants]
 17 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   17 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.1  (3.7) 
Gender 
[Units: Participants]
 
Female   17 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   17 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole.   [ Time Frame: 1 year ]

2.  Secondary:   Ovarian Function Suppression (OFS) Combined With Aromatase Inhibition Combined With Intravenous Bisphosphonate Therapy on Bone Mineral Density.   [ Time Frame: 2 years ]

3.  Secondary:   The Effect of OFS Combined With Aromatase Inhibitor Therapy on the Incidence and Severity of Menopausal Symptoms, Sexual Dysfunction, Musculoskeletal Complaints, Other Side Effects and Overall Quality of Life.   [ Time Frame: 2 years ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Ann Partridge, MD, MPH
Organization: Dana-Farber Cancer Institute
phone: 617.632.3800
e-mail: ann_partridge@dfci.harvard.edu



Responsible Party: Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00903162     History of Changes
Other Study ID Numbers: 08-280
Study First Received: May 5, 2009
Results First Received: June 19, 2015
Last Updated: March 18, 2016
Health Authority: United States: Institutional Review Board