← Back to Search

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.

Must not have

History of allergic reactions or hypersensitivity to compounds of similar chemical or biologic composition to anastrozole or letrozole.

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

No Placebo-Only Group

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.

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.

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

Select...

I am a woman aged 18 or older.

Select...

I have a suitable tumor tissue sample for study, not just from a fine needle aspiration.

Select...

My cancer is not driven by high levels of HER2.

Select...

I can take care of myself but may not be able to do heavy physical work.

Select...

My liver and kidneys are functioning within the normal range.

Select...

My breast cancer is sensitive to hormones and has a high estrogen receptor score.

Select...

My breast cancer is confirmed to be adenocarcinoma.

Select...

My breast cancer is in stages I-III and the tumor is at least 2.0 cm large.

Select...

I am postmenopausal, having had no periods for 12 months or my ovaries surgically removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am allergic to medications similar to anastrozole or letrozole.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ b,2-obtained 2-4 weeks after initiation of ai therapy( for persons rec. extended neoadjuvant tx)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent change in proliferative index (Ki67) after treatment with the standard dose anastrozole or letrozole in normal, obese, and overweight patients

Secondary study objectives

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 study objectives

Metabolomic Profiling