Aromatase Inhibitor Host Factors Study

NCT01669343 | Completed Results

• 1 other identifier: AI Host Factors
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Breast Neoplasms

Keywords

Aromatase Inhibitors

Outcome Measures

Primary Outcomes (5)

• Part A Correlation of Day 29 Estradiol With BMI

  Determine if estradiol levels vary with BMI levels after 28 days of monitored adherence to standard dose letrozole, by calculating the Pearson correlation between estradiol and log-transformed BMI

  Day 29

• Part A Correlation of Day 29 Estrone With BMI

  Determine if estrone levels vary with BMI levels after 28 days of monitored adherence to standard dose letrozole, by calculating the Pearson correlation between estrone and log-transformed BMI

  Day 29

• Part A Correlation of Day 29 Estradiol With Vitamin D

  Determine if estradiol levels vary with Vitamin D levels levels after 28 days of monitored adherence to standard dose letrozole, by calculating the Pearson correlation between estradiol and log-transformed Vitamin D level

  Day 29

• Part A Correlation of Day 29 Estrone With Vitamin D

  Determine if estrone levels vary with Vitamin D levels levels after 28 days of monitored adherence to standard dose letrozole, by calculating the Pearson correlation between estrone and log-transformed Vitamin D level

  Day 29

• Part B Change in Estradiol Level After Double Dose of Letrozole

  In overweight/obese patients enrolled in part B, determine if blood levels of estradiol levels changed from before to after the double dose of letrozole

  Day 29 to Day 58

Secondary Outcomes (3)

• Plasma Letrozole

  Day 29 and day 58

• Endocrine Symptoms During Part A of Study

  baseline, day 29 (end of part A)

• Endocrine Symptoms During Part B of the Study

  day 29 (end of part A) and day 58 (end of part B)

Other Outcomes (1)

• Musculoskeletal Symptoms

  baseline (day 1), day 29 (end of part A) and day 58 (end of part B)

Study Arms (1)

Post-menopausal Women Using Adjuvant Letrozole

OTHER

Part A Routine Care Letrozole; Part B Double Dose Letrozole in overweight/obese participants

Drug: Letrozole

Interventions

Letrozole DRUG

Part A Monitor standard of care letrozole use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period. Part B In overweight/obese participants who completed Part A, provide a double dose of letrozole and monitor use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period.

Also known as: Femara

Post-menopausal Women Using Adjuvant Letrozole

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known abnormal liver or renal function defined by:
• Serum Creatinine \> 1.25 times institutional upper limit of normal (ULN) or Calculated Creatinine Clearance \< 40 mL/min
• Serum Bilirubin, Aspartate transaminase (AST) or alanine transaminase (ALT) \> 1.5 times ULN
• Presence of persistent local or known metastatic cancer

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (3)

Princess Margaret Hospital

Toronto, Ontario, M5G 1M9, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Women's College Hospital

Toronto, Ontario, M5S 1B1, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. David Cescon
• Organization: Princess Margaret Hospital

dave.cescon@uhn.on.ca

416-946-2000

Study Officials

• Srikala Sridhar, M.D.

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2012
• First Posted: August 21, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 13, 2021
• Results First Posted: May 13, 2021

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Up to and including 5 years from publication of the related manuscript (Elliott, Mitchell J et al. "Association between BMI, vitamin D, and estrogen levels in postmenopausal women using adjuvant letrozole: a prospective study." NPJ breast cancer vol. 6 22. 12 Jun. 2020)
• Access Criteria: Reasonable request

Locations

CA (3)