N/A N=121 Treatment

Aromatase Inhibitor Host Factors Study

Breast Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT01669343 ↗

Enrolled (actual)

121

Serious AEs

1.7%

Results posted

May 2021

Primary outcome: Primary: Part A Correlation of Day 29 Estradiol With BMI — 0.06 correlation coefficient

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Letrozole (Drug)
Age: Pediatric, Adult, Older Adult
Sex: Female
Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Part A Correlation of Day 29 Estradiol With BMI	0.06	—
PRIMARY Part A Correlation of Day 29 Estrone With BMI	0.07	—
PRIMARY Part A Correlation of Day 29 Estradiol With Vitamin D	-0.04	—
PRIMARY Part A Correlation of Day 29 Estrone With Vitamin D	0.04	—
PRIMARY Part B Change in Estradiol Level After Double Dose of Letrozole	0.1	—
SECONDARY Plasma Letrozole	—	—
SECONDARY Endocrine Symptoms During Part A of Study	62.4; 62.9	—
SECONDARY Endocrine Symptoms During Part B of the Study	61.7; 61.2	—

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.

Eligibility 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:
Serum Creatinine > 1.25 times institutional upper limit of normal (ULN) or Calculated Creatinine Clearance 1.5 times ULN
Presence of persistent local or known metastatic cancer

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01669343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.