Overview

This trial is active, not recruiting.

Condition breast neoplasms
Treatment letrozole
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

Summary

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

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
letrozole 2.5 mg tablet,once daily for 28 days
letrozole
Active Comparator Arm receives 2.5 mg letrozole and Experimental Arm receives 5.0 mg letrozole
(Experimental)
letrozole 2.5 mg tablet, two tablets,once daily for 28 days
letrozole
Active Comparator Arm receives 2.5 mg letrozole and Experimental Arm receives 5.0 mg letrozole

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Plasma Letrozole
time frame: baseline, day 29 and day 58
Endocrine Symptoms
time frame: baseline, day 29 (end of part A) and day 58 (end of part B)

Eligibility Criteria

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

Additional Information

Official title Patient-related Predictors of Estrogen Suppression in Postmenopausal Women Using Adjuvant Letrozole
Principal investigator Srikala Sridhar, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Samuel Lunenfeld Research Institute, Mount Sinai Hospital.