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Aromatase Inhibitor

Letrozole for Infertility

Phase 4

Waitlist Available

Led By Glenn Schattman, MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is testing two ways of giving Letrozole to breast cancer patients who are preserving their fertility before starting other treatments. Letrozole helps lower estrogen levels by blocking an enzyme that produces estrogen. The goal is to find out which method keeps estrogen levels lower and improves egg quality and quantity. Letrozole is commonly used in breast cancer treatment and fertility preservation.

Eligible Conditions

Infertility
Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mature Oocyte Yield

Percent of Mature Oocyte Yield

Secondary study objectives

AF Count

AMH ng/ml (Cycle Day 2)

Breast Cancer Recurrence Rate

+11 more

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Titrated dose LetrozoleExperimental Treatment1 Intervention

Patients who are randomized to the titrated dose of Letrozole, will start gonadotropins in the evening of day #2 of their menstrual cycle with injectable follicle stimulating hormone (FSH) and human menopausal gonadotropin (HMG). Oral Letrozole will be added to the stimulation in the following titrated regimen.

Group II: Fixed dose LetrozoleActive Control1 Intervention

Patients who are randomized to fixed dose Letrozole will start Letrozole 5mg daily (orally) on the second day of their menstrual cycle and then gonadotropins on the fourth day of their menstrual cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Letrozole

2002

Completed Phase 4

~3590

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