Aromatase Inhibitor Host Factors Study

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Female

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 (BMI) > 25 kg/m2 to assess the effect of double AI dose on estrogen levels.

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Treatments: Aromatase Inhibitors; Letrozole

Criteria

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, Aspartate transaminase (AST) or alanine transaminase (ALT) > 1.5 times ULN

• Presence of persistent local or known metastatic cancer