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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

No Placebo-Only Group

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 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

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

Acne

Scoliosis

Hair loss

Sacroiliitis

Neuro event

100%

80%

60%

40%

20%

Study treatment Arm

Anastrozole

Letrozole

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 8Eligibility criteria met