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Aromatase Inhibitor
RCT of Fixed vs Titrated Letrozole in Breast Cancer Patient Undergoing IVF
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
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 moreSide effects data
From 2018 Phase 4 trial • 79 Patients • NCT0213753810%
Fracture
8%
Acne
5%
Scoliosis
3%
Hair loss
3%
Sacroiliitis
3%
Neuro event
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,092 Previous Clinical Trials
1,154,745 Total Patients Enrolled
24 Trials studying Infertility
8,474 Patients Enrolled for Infertility
Glenn Schattman, MDPrincipal InvestigatorWeill Cornell Medical Cornell
4 Previous Clinical Trials
331 Total Patients Enrolled