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Aromatase Inhibitor
Aromatase Inhibitor Therapy for Breast Cancer (NAOMI Trial)
Phase 2
Recruiting
Led By Mary D Chamberlin, MD
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologic documentation of invasive breast cancer by core needle or incisional biopsy with excess baseline biopsy tumor tissue available for research use
Women over 18 years of age for whom neoadjuvant treatment with an aromatase inhibitor would be clinically indicated and who are surgically, medically, or naturally post-menopausal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 4-12 weeks
Awards & highlights
NAOMI Trial Summary
This trial tests whether the aromatase inhibitor letrozole helps treat post-menopausal women with early to advanced stage ER+, HER2- breast cancer.
Who is the study for?
The NAOMI trial is for post-menopausal women over 18 with Stage I-III ER+ and HER2- breast cancer. Participants must have a tumor ≥1cm, not received prior endocrine therapy for any cancer, and meet specific blood criteria. Pregnant or lactating women are excluded.Check my eligibility
What is being tested?
This study tests Letrozole as pre-surgery treatment in eligible women to see how the drug affects their breast tumors. It involves taking Letrozole for 4 to 12 weeks before surgery, with molecular analysis of tumor samples before and after treatment.See study design
What are the potential side effects?
Letrozole may cause joint pain, hot flashes, weakness, fatigue, increased sweating and cholesterol levels. Rarely it can lead to bone thinning (osteoporosis) or trigger allergic reactions.
NAOMI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer diagnosis was confirmed through a biopsy, and there's extra tissue available for research.
Select...
I am a woman over 18, post-menopausal, and need hormone therapy before surgery.
Select...
I have early to mid-stage breast cancer and plan to have surgery to remove the tumor.
Select...
My breast cancer is mostly estrogen receptor positive.
Select...
My cancer is not driven by the HER2 protein.
NAOMI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 4-12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 4-12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Tumor CPT1-alpha levels
Secondary outcome measures
Change in tumor ACC histoscore
Change in tumor CD36 histoscore
Change in tumor CPT1-alpha histoscore
+4 moreSide effects data
From 2011 Phase 2 trial • 160 Patients • NCT0086721713%
Joint Function
9%
Arthralgia
8%
Joint Pain
8%
Fatigue
6%
Nausea
4%
Hot Flashes
4%
Pain - Back
1%
Pain - Hip
1%
Cardiac Changes
1%
Supraventricular arryhthmia
1%
Wound Complications
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vitamin D
Placebo
NAOMI Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Letrozole 2.5mg tablet administered once daily for 4 to ~12 weeks (window of + 4 weeks for surgical scheduling flexibility) final dose taken the day of surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letrozole 2.5mg
2019
Completed Phase 4
~840
Find a Location
Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
526 Previous Clinical Trials
2,541,234 Total Patients Enrolled
28 Trials studying Breast Cancer
2,352,802 Patients Enrolled for Breast Cancer
Mary D Chamberlin, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood tests show a normal level of white blood cells and platelets, and your liver function is within normal limits.I have received hormone therapy for cancer.Your tumor must be at least 1 centimeter in size to provide enough tissue for testing.My breast cancer diagnosis was confirmed through a biopsy, and there's extra tissue available for research.I am a woman over 18, post-menopausal, and need hormone therapy before surgery.I have early to mid-stage breast cancer and plan to have surgery to remove the tumor.I am receiving initial treatment for breast cancer, but I can take bisphosphonates for bone symptoms.I have cancer in more than one location and am a candidate for hormone therapy before surgery.My breast cancer is mostly estrogen receptor positive.My cancer is not driven by the HER2 protein.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
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 test subjects are a part of this research project?
"That is accurate. The clinical trial, as indicated on the website clinicaltrials.gov, is currently looking for patients to enroll. This particular trial was originally posted on 8/13/2021 and was last edited on 11/5/2021. 28 patients are needed at 2 locations."
Answered by AI
Has the Federal Drug Administration cleared Letrozole for public use?
"Although there is evidence that Letrozole 2.5mg is safe, its efficacy has not been tested yet. Consequently, it received a score of 2."
Answered by AI
What are some of the common conditions that Letrozole 2.5mg is used to help alleviate?
"Letrozole 2.5mg is most often used as a breast cancer treatment, though it can be effective in managing anovulatory cycles, tamoxifen side effects, and postmenopausal symptoms."
Answered by AI
What other scientific research has been conducted using Letrozole 2.5mg?
"There are one hundred and sixty-four different studies currently underway that focus on Letrozole 2.5mg. Many of these trials are in their third phase, with 44 total. Additionally, while many of the clinical trials for Letrozole 2.5mg originate from San Francisco, California, there are 12,424 locations running tests related to this medication."
Answered by AI
Are researchers still signing up volunteers for this experiment?
"That is accurate. The website clinicaltrials.gov has the latest information on this study, which was created on 8/13/2021 and edited on 11/5/2021. 28 individuals are needed for the research project, which is being conducted at 2 locations."
Answered by AI
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