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Anti-estrogen

Aromatase Inhibitors for Breast Cancer in Overweight and Obese Women

N/A
Recruiting
Led By Emily C Bellavance, M.D.
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female greater than or equal to 18 years.
Patients must have an adequate tumor tissue sample prior to enrollment available for correlative studies as defined below: Core needle biopsy or incisional biopsy samples that can provide ≥ 5 unstained sections of 5 micron thickness. Fine needle aspiration (FNA) sample alone is not sufficient.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up b,2-obtained 2-4 weeks after initiation of ai therapy( for persons rec. extended neoadjuvant tx)
Awards & highlights

Study Summary

This trial is testing whether AIs work differently in women with higher body fat compared to women with lower body fat.

Who is the study for?
This trial is for postmenopausal women with hormone-sensitive, early-stage breast cancer who haven't had previous treatments for their current condition. They must have a tumor at least 2 cm large and be in good enough health to participate. Women with higher body fat are of particular interest to see if they respond differently to the treatment.Check my eligibility
What is being tested?
The study tests whether overweight or obese women respond differently to Anastrozole (Arimidex®) and Letrozole (Femara®), which are drugs that reduce estrogen production used in early-stage breast cancer treatment. The effectiveness of these drugs may vary based on body fat levels.See study design
What are the potential side effects?
Anastrozole and Letrozole can cause hot flashes, joint pain, weakness, sore throat, high blood pressure, depression, nausea, and osteoporosis. These side effects result from lowering estrogen levels in the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 18 or older.
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I have a suitable tumor tissue sample for study, not just from a fine needle aspiration.
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My cancer is not driven by high levels of HER2.
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I can take care of myself but may not be able to do heavy physical work.
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My liver and kidneys are functioning within the normal range.
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My breast cancer is sensitive to hormones and has a high estrogen receptor score.
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My breast cancer is confirmed to be adenocarcinoma.
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My breast cancer is in stages I-III and the tumor is at least 2.0 cm large.
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I am postmenopausal, having had no periods for 12 months or my ovaries surgically removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~b,2-obtained 2-4 weeks after initiation of ai therapy( for persons rec. extended neoadjuvant tx)
This trial's timeline: 3 weeks for screening, Varies for treatment, and b,2-obtained 2-4 weeks after initiation of ai therapy( for persons rec. extended neoadjuvant tx) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent change in proliferative index (Ki67) after treatment with the standard dose anastrozole or letrozole in normal, obese, and overweight patients
Secondary outcome measures
To assess estradiol levels at baseline and after treatment (in primary ER positive breast tumors)
To evaluate differences in Oncotype Dx
To evaluate differences in baseline GP88 level
+1 more
Other outcome measures
Metabolomic Profiling

Trial Design

6Treatment groups
Active Control
Group I: Cohort 4: Normal Weight LetrozoleActive Control1 Intervention
Cohort 4: Patients with BMI < 25.0 kg/m2 treating with letrozole
Group II: Cohort 1: Normal Weight AnastrozoleActive Control1 Intervention
Cohort 1: Patients with BMI < 25.0 kg/m2 treated with anastrozole
Group III: Cohort 2: Overweight AnastrozoleActive Control1 Intervention
Cohort 2: Patients with BMI ≥ 25.0-29.9 kg/m2 treated with anastrozole
Group IV: Cohort 3: ObeseActive Control1 Intervention
Cohort 3: Patients with BMI ≥ 30 kg/m2 treated with anastrozole
Group V: Cohort 5: Overweight LetrozoleActive Control1 Intervention
Cohort 5: Patients with BMI ≥ 25.0-29.9 kg/m2 treating with letrozole
Group VI: Cohort 6: Obese LetrozoleActive Control1 Intervention
Cohort 6: Patients with BMI ≥ 30 kg/m2 treating with letrozole

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
693 Previous Clinical Trials
376,818 Total Patients Enrolled
11 Trials studying Breast Cancer
271 Patients Enrolled for Breast Cancer
Emily C Bellavance, M.D.Principal InvestigatorUniversity of Maryland, Baltimore

Media Library

Anastrozole (Anti-estrogen) Clinical Trial Eligibility Overview. Trial Name: NCT02095184 — N/A
Breast Cancer Research Study Groups: Cohort 4: Normal Weight Letrozole, Cohort 1: Normal Weight Anastrozole, Cohort 2: Overweight Anastrozole, Cohort 3: Obese, Cohort 5: Overweight Letrozole, Cohort 6: Obese Letrozole
Breast Cancer Clinical Trial 2023: Anastrozole Highlights & Side Effects. Trial Name: NCT02095184 — N/A
Anastrozole (Anti-estrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02095184 — N/A
~9 spots leftby Jun 2025
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