Status:
COMPLETED
Extended Endocrine Therapy for Premenopausal Women With Breast Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Novartis
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety and tolerability of the combination of two drugs (letrozole and leuprolide) in women who have already taken tamoxifen for at least 4.5 years. Letro...
Detailed Description
* 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 b...
Eligibility Criteria
Inclusion
- Women 18 years of age or older
- History of invasive ER+ or PR+ breast cancer treated with at least 4.5 years of tamoxifen
- No current evidence of recurrent invasive disease or metastatic disease. Patients may have a history of bilateral breast cancer
- Premenopausal (estradiol level in premenopausal range, \>20pg/ml, within the prior 28 days)
- Liver function tests and creatinine \<2.5 times the upper limit of normal within the 28 days prior to enrollment
- ECOG Performance Status 0-1
- Must agree to use non-hormonal contraception (condoms, diaphragm, IUD, sterilization, abstinence, etc) and no other hormonal therapy during trial and until 3 months after letrozole is stopped
- Negative pregnancy test within 14 days prior to enrollment
- Patient must be able to speak, read and write in English
Exclusion
- Previous treatment with an oral or IV bisphosphonate in the prior two years
- History of cancer other than breast cancer within 5 years excluding basal/squamous cell skin carcinoma in situ of the cervix
- Women with evidence of current local recurrence or metastatic breast cancer
- Pregnant women
- Nursing women
- Women who are currently taking tamoxifen and are unwilling to stop this medication
- Women with a known deleterious BRCA 1 or BRCA 2 mutation
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00903162
Start Date
May 1 2009
End Date
September 1 2014
Last Update
April 18 2016
Active Locations (4)
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1
University of Colorado
Denver, Colorado, United States, 80217
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
4
Newton Wellesley Hospital
Newton, Massachusetts, United States, 02462