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Aromatase Inhibitor

Letrozole for Breast Cancer

Phase 2
Waitlist Available
Led By Nisha Unni, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status 0-2
Clinical stage operable I, II or III invasive mammary carcinoma, which is ER-positive by IHC and HER2-negative by Herceptest (0 or 1+) or not amplified by in situ hybridization as per routine clinical testing
Must not have
Severe uncontrolled malabsorption condition or disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 8 to 30 days
Awards & highlights

Summary

This trial is for postmenopausal women with newly diagnosed, operable, estrogen receptor positive and HER2 negative breast cancer. Participants will take letrozole for 1-4 weeks before surgery. The trial will help assess the effects of letrozole on the primary tumor before surgery.

Who is the study for?
This trial is for postmenopausal women with operable hormone-sensitive breast cancer that's ER-positive and HER2-negative. Candidates should not have had prior chemotherapy for this cancer, can have a history of contralateral breast cancer if there's no recurrence, must be off tamoxifen or raloxifene for at least 14 days, and stopped hormone replacement therapy at least 7 days before starting the trial.
What is being tested?
The study tests Letrozole in a short pre-surgical course (1-4 weeks) followed by standard surgical removal of the tumor. It aims to see how effective Letrozole is when given right before surgery in shrinking tumors in these specific patients.
What are the potential side effects?
Letrozole may cause hot flashes, joint pain, weakness, fatigue, increased sweating and cholesterol levels. Rarely it might lead to bone thinning or osteoporosis over long-term use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and perform daily activities.
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My breast cancer is early stage, ER-positive, and HER2-negative.
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I am scheduled for a partial or complete breast removal surgery.
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I am a woman over 18 and have gone through menopause.
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I have not had chemotherapy for my current breast cancer.
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My tumor is at least 1 cm big and can be measured by an exam or scan.
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I have a visible tumor that hasn't been fully removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a severe condition that affects how my body absorbs nutrients.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 8 to 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 8 to 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Measure Ki67 index in highly hormone-dependent breast cancers vs. those that are not

Side effects data

From 2018 Phase 4 trial • 79 Patients • NCT02137538
10%
Fracture
8%
Acne
5%
Scoliosis
3%
Hair loss
3%
Sacroiliitis
3%
Neuro event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anastrozole
Letrozole

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Drug: letrozole Take by mouth at a dose of 2.5 mg on days 7-30 Other: Blood Collection Blood used for gene expression analysis and reverse transcriptase-polymerase chain reaction Procedure: biopsy/lumpectomy/mastectomy Tissue collection,Surgery to remove tumor, Tumor tissues used for laboratory biomarker analysis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letrozole
2002
Completed Phase 4
~3590

Find a Location

Who is running the clinical trial?

Cancer Prevention Research Institute of TexasOTHER
52 Previous Clinical Trials
98,899 Total Patients Enrolled
8 Trials studying Breast Cancer
18,905 Patients Enrolled for Breast Cancer
University of Texas Southwestern Medical CenterLead Sponsor
1,072 Previous Clinical Trials
1,056,201 Total Patients Enrolled
23 Trials studying Breast Cancer
6,264 Patients Enrolled for Breast Cancer
Nisha Unni, MDPrincipal Investigator - University of Texas Southwestern Medical Center
Children's Medical Center of Dallas, The University of Texas Southwestern Medical Center At Dallas, UT Southwestern Medical Center-Zale Lipshy Campus

Media Library

Letrozole (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03747042 — Phase 2
Breast Cancer Research Study Groups: Treatment
Breast Cancer Clinical Trial 2023: Letrozole Highlights & Side Effects. Trial Name: NCT03747042 — Phase 2
Letrozole (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03747042 — Phase 2
~2 spots leftby Nov 2024
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