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Aromatase Inhibitor Host Factors Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT01669343
First received: August 15, 2012
Last updated: April 29, 2016
Last verified: April 2016
  Purpose

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.


Condition Intervention
Breast Neoplasms
Drug: Letrozole

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Patient-related Predictors of Estrogen Suppression in Postmenopausal Women Using Adjuvant Letrozole

Resource links provided by NLM:


Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:
  • Change in Serum Estradiol from Baseline to day 29 [ Time Frame: Baseline and day 29 ] [ Designated as safety issue: No ]
  • Change in Serum Estradiol from Baseline to day 58 [ Time Frame: Baseline and day 58 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma Letrozole [ Time Frame: baseline, day 29 and day 58 ] [ Designated as safety issue: No ]
  • Endocrine Symptoms [ Time Frame: baseline, day 29 (end of part A) and day 58 (end of part B) ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Musculoskeletal Symptoms [ Time Frame: baseline (day 1), day 29 (end of part A) and day 58 (end of part B) ] [ Designated as safety issue: Yes ]

Enrollment: 113
Study Start Date: September 2012
Estimated Study Completion Date: December 2017
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Part A letrozole 2.5 mg
letrozole 2.5 mg tablet,once daily for 28 days
Drug: Letrozole
Active Comparator Arm receives 2.5 mg letrozole and Experimental Arm receives 5.0 mg letrozole
Experimental: Part B letrozole 5.0 mg
letrozole 2.5 mg tablet, two tablets,once daily for 28 days
Drug: Letrozole
Active Comparator Arm receives 2.5 mg letrozole and Experimental Arm receives 5.0 mg letrozole

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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, AST or ALT > 1.5 times ULN
  • Presence of persistent local or known metastatic cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669343

Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 1M9
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B1
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Principal Investigator: Srikala Sridhar, MD Mount Sinai Hospital, New York
  More Information

Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01669343     History of Changes
Other Study ID Numbers: AI Host Factors 
Study First Received: August 15, 2012
Last Updated: April 29, 2016
Health Authority: Canada: Health Canada

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Aromatase Inhibitors

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Aromatase Inhibitors
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016