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Aromatase Inhibitor

Letrozole for Breast Cancer

Q: What are some conditions that Letrozole can help treat?

<p>Letrozole is frequently used to treat <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a>. However, it can also be used to regulate anovulatory cycles, as well as for tamoxifen and postmenopausal women.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 8 to 30 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 8 to 30 days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Acne

Scoliosis

Hair loss

Sacroiliitis

Neuro event

100%

80%

60%

40%

20%

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

~3240

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cancer Prevention Research Institute of TexasOTHER

50 Previous Clinical Trials

98,377 Total Patients Enrolled

8 Trials studying Breast Cancer

18,905 Patients Enrolled for Breast Cancer

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,738 Total Patients Enrolled

22 Trials studying Breast Cancer

6,262 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other research studies have included Letrozole as a part of their investigation?

"As of now, 163 different clinical studies are investigating the efficacy of letrozole. Out of those, 44 are in phase 3. The majority of these studies are based in San Francisco, but there are 12337 total locations running these trials."

Answered by AI

What are some conditions that Letrozole can help treat?

"Letrozole is frequently used to treat breast cancer. However, it can also be used to regulate anovulatory cycles, as well as for tamoxifen and postmenopausal women."

Answered by AI

Has the FDA cleared Letrozole for public use?

"While there is some data supporting the safety of Letrozole, it did not receive a higher score because there is no evidence currently of the medication's efficacy."

Answered by AI

Are there any appointments left for this research project?

"Unfortunately, this study is no longer enrolling patients. The details of the clinical trial were first posted on 27th November 2018 and was last updated on the 6th of June, 2022. However, if you are interested in other studies, there are 2375 trials for neoplasms and 163 for Letrozole that are still recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Letrozole in Post-Menopausal Patients With Operable Hormone-Sensitive Breast Cancer

Nisha Unni 2018. "Letrozole in Post-Menopausal Patients With Operable Hormone-Sensitive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03747042.

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