Extended Endocrine Therapy for Premenopausal Women With Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00903162|
Recruitment Status : Completed
First Posted : May 18, 2009
Results First Posted : February 4, 2016
Last Update Posted : April 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: leuprolide Drug: letrozole Drug: zoledronic acid||Phase 2|
- Participants will be given a monthly intramuscular injection of leuprolide. Six to eight weeks after the first leuprolide injection, participants will be instructed to begin taking letrozole pills by mouth at home each day.
- During this research study, participants will also be offered injections of zoledronic acid to preserve bone mineral density. If desire, these injections will be given every 6 months for a total of 4 injections during the course of the research study.
- The treatments in this research study may increase the risk of bone density loss, so vitamin D and calcium supplements will be recommended to participants.
- The following tests and procedures will be performed during the research study: Physical Exam (every visit); Blood tests; Urine test (beginning and end of treatment); Imaging (annual mammograms); Bone Density (DXA) Scan (beginning and end of treatment); Questionnaires (throughout the study).
- Participants will be on this study for about two years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Extended Endocrine Therapy for Premenopausal Women With Breast Cancer|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||September 2014|
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.
Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years
Other Name: LupronDrug: letrozole
Taken orally once a day 6-8 weeks after initial leuprolide administration
Other Name: FemaraDrug: zoledronic acid
If desired, given intravenously every 6 months for a total of 4 injections (optional)
Other Name: Zometa
- Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole. [ Time Frame: 1 year ]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.
- Ovarian Function Suppression (OFS) Combined With Aromatase Inhibition Combined With Intravenous Bisphosphonate Therapy on Bone Mineral Density. [ Time Frame: 2 years ]Ovarian function suppression (OFS) combined with aromatase inhibition combined with intravenous bisphosphonate therapy on bone mineral density in this patient population.
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903162
|United States, Colorado|
|University of Colorado|
|Denver, Colorado, United States, 80217|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02115|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Newton Wellesley Hospital|
|Newton, Massachusetts, United States, 02462|
|Principal Investigator:||Ann Partridge, MD||Dana-Farber Cancer Institute|