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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 belowSelect...
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 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)
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 moreOther 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
688 Previous Clinical Trials
374,566 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman aged 18 or older.I haven't had chemo, radiation, or hormone therapy for my current breast cancer.I have a suitable tumor tissue sample for study, not just from a fine needle aspiration.My cancer is not driven by high levels of HER2.I can take care of myself but may not be able to do heavy physical work.My liver and kidneys are functioning within the normal range.My breast cancer is sensitive to hormones and has a high estrogen receptor score.I have not had any cancer except breast cancer, skin cancer, or treated cervical cancer in the last 3 years.My breast cancer is confirmed to be adenocarcinoma.I am allergic to medications similar to anastrozole or letrozole.My breast cancer is in stages I-III and the tumor is at least 2.0 cm large.I am postmenopausal, having had no periods for 12 months or my ovaries surgically removed.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 4: Normal Weight Letrozole
- Group 2: Cohort 1: Normal Weight Anastrozole
- Group 3: Cohort 2: Overweight Anastrozole
- Group 4: Cohort 3: Obese
- Group 5: Cohort 5: Overweight Letrozole
- Group 6: Cohort 6: Obese Letrozole
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are receiving treatment in this research?
"Indeed, clinicaltrials.gov data affirms that this investigation is actively recruiting patients. This research was initially announced on May 25th 2015 and has been recently revised as of April 29th 2022. 90 people need to be enlisted from a single medical site."
Answered by AI
Is admission to this trial still accepting new participants?
"Clinicaltrials.gov reveals that this study is actively recruiting participants and has been since May 25th 2015, with the latest update occuring on April 29th 2022."
Answered by AI
What maladies are typically addressed with Cohort 1: Normal Weight Anastrozole?
"Cohort 1: Normal Weight Anastrozole is a typical prescription for those who have completed two to three years of tamoxifen treatment. Additionally, it can be beneficial in treating postmenopausal women with invasive early-stage breast cancer or simply as an alternative to Tamoxifen itself."
Answered by AI
Are there any historical accounts of clinical research conducted on the Normal Weight Anastrozole population?
"Currently, 44 trials studying Cohort 1: Normal Weight Anastrozole are in Phase 3 with a total of 175 studies. San Francisco, California is home to several such experiments while 12382 other sites across the globe also have active research projects for this cohort."
Answered by AI
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