What side effects are associated with this type of intervention?

Common side effects of infertility treatments involving Letrozole plus Gonadotropin and Tamoxifen plus Gonadotropin include hot flashes, headaches, and gastrointestinal disturbances such as nausea. Letrozole can lead to lower estradiol levels, which may affect fertilization and embryo quality. Gonadotropins can cause ovarian hyperstimulation syndrome (OHSS), characterized by swollen, painful ovaries. Both treatments aim to increase the number of mature oocytes, but they may also lead to multiple pregnancies. Overall, these treatments are generally well-tolerated, but monitoring by a healthcare provider is essential to manage potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of infertility, including those similar to Letrozole plus Gonadotropin and Tamoxifen plus Gonadotropin. Letrozole, an aromatase inhibitor, is used off-label for ovulation induction in women with polycystic ovary syndrome (PCOS) who do not respond to clomiphene citrate. Gonadotropins, such as human menopausal gonadotropin (hMG) and recombinant follicle-stimulating hormone (FSH), are FDA-approved for stimulating the ovaries to produce multiple follicles. Tamoxifen, a selective estrogen receptor modulator, is also used off-label for ovulation induction. These treatments aim to enhance fertility by promoting the development of multiple ovarian follicles.

What other types of research exist?

Promising novel alternatives for infertility treatment in 2024 include: 1) Elagolix, an oral GnRH antagonist, which has shown efficacy in managing endometriosis-associated pain and may improve fertility outcomes by reducing estrogen levels without the flare phenomenon seen with GnRH agonists. 2) Relugolix, another oral GnRH antagonist, which offers rapid suppression of gonadotropins and may be beneficial in controlled ovarian stimulation protocols. 3) Advances in personalized medicine approaches, such as the use of genetic profiling to tailor ovulation induction protocols to individual patient needs, optimizing drug selection and dosing for better outcomes.

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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

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing two medication combinations to help women with breast cancer preserve their fertility. It focuses on women with a specific type of breast cancer and aims to find out which combination helps produce more mature eggs. The medications work by managing hormone levels and stimulating the ovaries. Tamoxifen and letrozole have been used to safely manage hormone levels in breast cancer patients undergoing fertility preservation.

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.

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.

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.

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

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

Primary study objectives

Mature Oocyte Yield

Secondary study objectives

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

+5 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

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

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

~30110

Letrozole

2002

Completed Phase 4

~3590

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Letrozole plus Gonadotropin and Tamoxifen plus Gonadotropin are common treatments for infertility. Letrozole, an aromatase inhibitor, reduces estrogen production, leading to increased follicle-stimulating hormone (FSH) levels, which stimulates the ovaries to produce multiple follicles. Gonadotropins are hormones that directly stimulate the ovaries to produce multiple follicles. Tamoxifen, a selective estrogen receptor modulator (SERM), blocks estrogen receptors, also resulting in increased FSH levels and ovarian stimulation. These treatments are designed to enhance ovarian stimulation and improve oocyte yield, thereby increasing the chances of successful fertilization and pregnancy for infertility patients.

Fertility preservation for women with breast cancer: a multicentre randomized controlled trial on various ovarian stimulation protocols.Concomitant tamoxifen or letrozole for optimal oocyte yield during fertility preservation for breast cancer: the TAmoxifen or Letrozole in Estrogen Sensitive tumors (TALES) randomized clinical trial.Does daily co administration of gonadotropins and letrozole during the ovarian stimulation improve IVF outcome for poor and sub optimal responders?