Aromatase Inhibitor Host Factors Study
This trial is active, not recruiting.
|Sponsor||Samuel Lunenfeld Research Institute, Mount Sinai Hospital|
|Start date||September 2012|
|End date||June 2015|
|Trial size||113 participants|
|Trial identifier||NCT01669343, AI Host Factors|
The purpose of this study is to examine how key patient factors, including body size affect how well letrozole suppresses circulating estrogen levels.
This study has two components: (1) Part A - an observational phase to evaluate the impact of vitamin D and obesity on estrogen suppression in post-menopausal women already receiving letrozole treatment, and (2) Part B - an interventional phase for women with body mass index (BM) > 25 kg/m2.
If BMI or other patient factors reduce the effectiveness of letrozole, modifications to treatment recommendations and studies to test higher dosing of letrozole may be needed to maximize the benefit of this treatment and minimize the risk of the breast cancer coming back.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||pharmacokinetics/dynamics study|
|Intervention model||crossover assignment|
Change in Serum Estradiol from Baseline to day 29
time frame: Baseline and day 29
Change in Serum Estradiol from Baseline to day 58
time frame: Baseline and day 58
time frame: baseline, day 29 and day 58
time frame: baseline, day 29 (end of part A) and day 58 (end of part B)
Female participants of any age.
Inclusion Criteria: - Postmenopausal female patients - histological confirmed diagnosis of estrogen receptor and/or progesterone receptor positive breast cancer (Stage I-III) who have completed local therapy - Currently prescribed and taking letrozole 2.5 mg daily for a minimum of 3 months - Willing to provide written informed consent to participate - for the experimental arm: all of the above and body mass index (BMI) > 25 kg/m2 Exclusion Criteria: - Known abnormal liver or renal function defined by: 1. Serum Creatinine > 1.25 times institutional upper limit of normal (ULN) or Calculated Creatinine Clearance < 40 mL/min 2. Serum Bilirubin, AST or ALT > 1.5 times ULN - Presence of persistent local or known metastatic cancer
|Official title||Patient-related Predictors of Estrogen Suppression in Postmenopausal Women Using Adjuvant Letrozole|
|Principal investigator||Srikala Sridhar, MD|
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