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Aromatase Inhibitor

Tamoxifen + Letrozole for Fertility Preservation in Breast Cancer (TALES Trial)

Phase 3

Recruiting

Led By Mitchell Rosen, MD

Research Sponsored by University of California, San Francisco

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 up to 2 weeks

Awards & highlights

TALES Trial Summary

This trial looks at whether letrozole or tamoxifen, when used with gonadotropins, results in a higher number of eggs retrieved for fertility preservation in women with estrogen-receptor-positive breast cancer.

Who is the study for?

This trial is for adults over 18 who have been newly diagnosed with breast cancer and wish to preserve fertility before starting chemotherapy. They must want to undergo ovarian stimulation and egg retrieval.Check my eligibility

What is being tested?

The study is testing the effectiveness of two drugs, Tamoxifen and Letrozole, in increasing the number of eggs retrieved for preservation from patients with estrogen-sensitive tumors before they start cancer treatment.See study design

What are the potential side effects?

Possible side effects include hot flashes, mood swings, joint pain, and fatigue. There may also be a risk of blood clots or changes in menstrual flow.

TALES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 weeks

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

Treatment Details

Study Objectives

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

Primary outcome measures

Mature Oocyte Yield

Secondary outcome measures

Compare change in androgen levels during the ovarian stimulation cycle

Compare change in estrogen in follicular fluid

Compare change in estrogen levels during the ovarian stimulation cycle

+6 more

TALES Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: ER Positive - TamoxifenExperimental Treatment1 Intervention

Group II: ER Positive - LetrozoleExperimental Treatment1 Intervention

Group III: ER NegativeActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tamoxifen

2005

Completed Phase 4

~29860

Letrozole

2002

Completed Phase 4

~3240

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,500 Previous Clinical Trials

15,236,327 Total Patients Enrolled

18 Trials studying Infertility

8,725 Patients Enrolled for Infertility

Mitchell Rosen, MDPrincipal InvestigatorUniversity of California, San Francisco

4 Previous Clinical Trials

502 Total Patients Enrolled

3 Trials studying Infertility

500 Patients Enrolled for Infertility

Media Library

Letrozole (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03011684 — Phase 3

Infertility Research Study Groups: ER Positive - Tamoxifen, ER Negative, ER Positive - Letrozole

Infertility Clinical Trial 2023: Letrozole Highlights & Side Effects. Trial Name: NCT03011684 — Phase 3

Letrozole (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03011684 — Phase 3

Infertility Patient Testimony for trial: Trial Name: NCT03011684 — Phase 3

Frequently Asked Questions

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

Has the Federal Drug Administration cleared Tamoxifen for public use?

"Tamoxifen is considered safe based on prior clinical data, receiving a score of 3."

Answered by AI

Are there any open slots for participants in this clinical trial?

"This information is available on clinicaltrials.gov. The trial in question was posted on 7/21/2016 and updated on 4/29/2022."

Answered by AI

What is the medication Tamoxifen typically used to treat?

"Tamoxifen is the standard of care for treating breast surgery. Additionally, this medication can be effective in managing estrogen receptors, and malignant neoplasms."

Answered by AI

Will this clinical trial accept patients that are over 20 years old?

"Following the age guidelines set by this trial's inclusion criteria, the youngest an individual can be to participate is 18 and the oldest they can be is 50."

Answered by AI

Are there any specific inclusion or exclusion criteria for this experiment?

"This research is looking for 144 individuals that have difficulty conceiving and are between 18-50 years old."

Answered by AI

Is Tamoxifen a common drug used in research?

"As of now, there are a total of 201 active clinical trials investigating Tamoxifen with 56 being in Phase 3. The epicentre for this research appears to be San Francisco, California; however, there are 13454 locations worldwide conducting these studies."

Answered by AI