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

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ClinicalTrials.gov Identifier: NCT00903162
Recruitment Status : Completed
First Posted : May 18, 2009
Results First Posted : February 4, 2016
Last Update Posted : April 18, 2016
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Novartis
Information provided by (Responsible Party):
Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: leuprolide
Drug: letrozole
Drug: zoledronic acid
Enrollment 17
Recruitment Details 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 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.
Arm/Group Title Letrozole-Leuprolide
Hide Arm/Group Description

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)

Period Title: Overall Study
Started 16
Completed 12
Not Completed 4
Arm/Group Title Letrozole-Leuprolide
Hide Arm/Group Description

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)

Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
Enrolled participants.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
45.1  (3.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
17
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants
17
1.Primary Outcome
Title Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole.
Hide Description The tolerability at one year of ovarian function suppression (OFS) using leuprolide and letrozole in this patient population. Specifically, the number of patients who discontinued treatment prior to one year due to toxicity.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Between September 15, 2009, and January 18, 2013, 17 patients were enrolled, but only 16 actually began protocol-directed treatment. Of the 16, 4 stopped treatment before completing even 1 year of protocol-directed therapy, owing to toxicity.
Arm/Group Title Letrozole-Leuprolide
Hide Arm/Group Description:

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)

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: participants
4
2.Secondary Outcome
Title Ovarian Function Suppression (OFS) Combined With Aromatase Inhibition Combined With Intravenous Bisphosphonate Therapy on Bone Mineral Density.
Hide Description Ovarian function suppression (OFS) combined with aromatase inhibition combined with intravenous bisphosphonate therapy on bone mineral density in this patient population.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This data was not collected nor analyzed because of too few participants to be meaningful.
Arm/Group Title Letrozole-Leuprolide
Hide Arm/Group Description:

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)

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title 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.
Hide Description 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 in this population.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This data was not collected nor analyzed because of too few participants to be meaningful.
Arm/Group Title Letrozole-Leuprolide
Hide Arm/Group Description:

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)

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events data were collected for the two years that patients were on study treatments.
Adverse Event Reporting Description Adverse events data were collected from all participants enrolled in the study.
 
Arm/Group Title Letrozole-Leuprolide
Hide Arm/Group Description

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)

All-Cause Mortality
Letrozole-Leuprolide
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Letrozole-Leuprolide
Affected / at Risk (%) # Events
Total   0/17 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Letrozole-Leuprolide
Affected / at Risk (%) # Events
Total   12/17 (70.59%)    
Endocrine disorders   
Hot Flashes * [1]  12/17 (70.59%)  12
Gastrointestinal disorders   
Nausea * [2]  3/17 (17.65%)  3
General disorders   
Flu-like Symptoms, Fever, or Rigors * [3]  2/17 (11.76%)  2
Fatigue * [4]  6/17 (35.29%)  6
Injection Site Reaction or Rash * [5]  3/17 (17.65%)  3
Musculoskeletal and connective tissue disorders   
Myalgia * [6]  12/17 (70.59%)  12
Nervous system disorders   
Headache * [7]  6/17 (35.29%)  6
Psychiatric disorders   
Insomnia * [8]  3/17 (17.65%)  3
Reproductive system and breast disorders   
Vaginal Dryness * [9]  11/17 (64.71%)  11
Sexual Dysfunction * [10]  4/17 (23.53%)  4
Vaginal Discharge * [11]  2/17 (11.76%)  2
*
Indicates events were collected by non-systematic assessment
[1]
Hot Flashes/Flushes
[2]
A disorder characterized by a queasy sensation and/or the urge to vomit.
[3]
A disorder characterized by a group of symptoms similar to those observed in patients with the flu. It includes fever, chills, body aches, malaise, loss of appetite and dry cough.
[4]
A disorder characterized by a state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities.
[5]
A disorder characterized by an intense adverse reaction (usually immunologic) developing at the site of an injection.
[6]
Muscle pain
[7]
disorder characterized by a sensation of marked discomfort in various parts of the head, not confined to the area of distribution of any nerve.
[8]
A disorder characterized by difficulty in falling asleep and/or remaining asleep.
[9]
Dryness of the vagina
[10]
A disorder characterized by a decrease in sexual desire or function.
[11]
A disorder characterized by vaginal secretions. Mucus produced by the cervical glands is discharged from the vagina naturally, especially during the childbearing years.
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
Responsible Party: Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00903162     History of Changes
Other Study ID Numbers: 08-280
First Submitted: May 5, 2009
First Posted: May 18, 2009
Results First Submitted: June 19, 2015
Results First Posted: February 4, 2016
Last Update Posted: April 18, 2016