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Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial (TALES)

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ClinicalTrials.gov Identifier: NCT03011684
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
Mitchell Rosen, M.D., University of California, San Francisco

Brief Summary:
Iatrogenic 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.

Condition or disease Intervention/treatment Phase
Infertility Drug: Tamoxifen Drug: Letrozole Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial
Study Start Date : January 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: ER Positive - Letrozole Drug: Letrozole
For ER Positive Randomization

Experimental: ER Positive - Tamoxifen Drug: Tamoxifen
For ER Positive Randomization

No Intervention: ER Negative



Primary Outcome Measures :
  1. Mature Oocyte Yield [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion/Exclusion Criteria:

  • Inclusions:

    • 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
  • Exclusions:

    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011684


Contacts
Contact: Mitchell Rosen, MD 415 353 7475

Locations
United States, California
University of California at San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Mitchell Rosen, M.D.       Mitchell.Rosen@ucsf.edu   
Contact: Joseph Letourneau       joseph.letourneau@ucsf.edu   
Principal Investigator: Mitchell Rosen, M.D.         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Mitchell Rosen, MD University of California, San Francisco

Responsible Party: Mitchell Rosen, M.D., Associate Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03011684     History of Changes
Other Study ID Numbers: TALES Trial
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017

Keywords provided by Mitchell Rosen, M.D., University of California, San Francisco:
Fertility Preservation
Breast Cancer

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Letrozole
Tamoxifen
Estrogens
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hormones
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents