Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial

NCT03011684 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: TALES TrialNCI-2017-0180916751
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 1

Brief Summary

Latrogenic infertility as a result of cancer treatment has a profound effect on long-term quality of life in survivors of reproductive-age cancers. Oocyte cryopreservation prior to cancer treatment has been associated with improved quality of life, with a potential ability to reduce long-term decision-related regret in cancer survivors. Though letrozole plus gonadotropin and and tamoxifen plus gonadotropin are currently routinely used worldwide in ovarian stimulation cycles for fertility preservation in patients with estrogen-receptor-positive breast cancer, it is not clear which of the two might lead to improved oocyte yield. Improved knowledge about the efficacy of these medications, with regard to oocyte yield, has the potential to significantly improve quality of life in reproductive-age breast cancer survivors.

Conditions

Infertility

Keywords

Fertility Preservation; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Mature Oocyte Yield

  To determine if the assigned stimulation regimen will result in a difference in mature (meiosis II) oocyte yield in patients with breast cancer who undergo ovarian stimulation for fertility preservation. An Effect Size of 3 mature oocytes, based on clinically significant difference of 2 embryos to transfer. An average of 2 embryos are transferred per freeze-thaw cycle. If \~75% of mature oocytes will become embryos that can be frozen, then 3 mature oocytes should yield \~2 embryos for transfer. This effect size would effectively mean an additional event of embryos transferred.

  Up to 2 weeks

Secondary Outcomes (9)

• Compare change in estrogen levels during the ovarian stimulation cycle

  Up to 2 weeks

• Compare change in progesterone levels during the ovarian stimulation cycle

  Up to 2 weeks

• Compare change in androgen levels during the ovarian stimulation cycle

  Up to 2 weeks

• Compare change in estrogen in follicular fluid

  Up to 2 weeks

• Compare change in letrozole in follicular fluid

  Up to 2 weeks

Study Arms (3)

Randomized ER Positive Participants (Letrozole)

EXPERIMENTAL

Participants will receive 5 mg of letrozole with the first day of non-investigational gonadotropin (letrozole-gonadotropin) and stopped on the day of oocyte retrieval.

Drug: Letrozole

Randomized ER Positive Participants (Tamoxifen)

EXPERIMENTAL

Participants will receive 20 mg of tamoxifen with the first day of non-investigational gonadotropin (tamoxifen-gonadotropin) and stopped on the day of oocyte retrieval

Drug: Tamoxifen

ER Negative (ER-) Participants

NO INTERVENTION

Participants whose disease is ER negative will be consented and used as a reference cohort and will receive no study related medication. The Gonadotropin received is non-investigational and part of usual care.

Interventions

Tamoxifen DRUG

Given orally

Also known as: Nolvadex, Soltamox

Randomized ER Positive Participants (Tamoxifen)

Letrozole DRUG

Given orally

Also known as: Femara

Randomized ER Positive Participants (Letrozole)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• New breast cancer diagnosis
• Has not yet begun chemotherapy
• Desires to undergo ovarian stimulation and oocyte retrieval prior to cancer treatment
• Age 18 years old or greater

You may not qualify if:

• Chemotherapy has already commenced or been completed
• History of recurrent breast cancer (with a prior history of chemotherapy)
• Stage IV breast cancer diagnosis (metastases remote from the breast)
• Patient's oncologist advises against the trial - in which case they can choose to receive stimulation with letrozole+gonadotropin
• Does not plan to undergo ovarian stimulation and oocyte retrieval prior to diagnosis
• Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow-up, or interpretation of study results
• Age less than 18 years old

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California at San Francisco

San Francisco, California, 94143, United States

RECRUITING

Related Publications (1)

• Letourneau J, Juarez-Hernandez F, Wald K, Ribeiro S, Wang A, McCulloch CE, Mok-Lin E, Dolezal M, Chien AJ, Cedars MI, Rosen M. 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. J Assist Reprod Genet. 2021 Sep;38(9):2455-2463. doi: 10.1007/s10815-021-02273-3. Epub 2021 Jul 26.

  PMID: 34312774 DERIVED

MeSH Terms

Conditions

Infertility; Breast Neoplasms

Interventions

Tamoxifen; Letrozole

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mitchell Rosen, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Wong

CONTACT

415-353-4305; Rebecca.Wong@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized at the time of enrollment to 1 of 2 experimental arms.

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 5, 2017
• Study Start: July 21, 2016
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)