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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 : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

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

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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
Actual Study Start Date : July 21, 2016
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

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: Up to 2 weeks ]
    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.


Secondary Outcome Measures :
  1. Compare change in estrogen levels during the ovarian stimulation cycle [ Time Frame: Up to 2 weeks ]
    Estrogen level data will be collected at baseline and after completion of the stimulation cycle

  2. Compare change in progesterone levels during the ovarian stimulation cycle [ Time Frame: Up to 2 weeks ]
    Progesterone level data will be collected at baseline and after completion of the stimulation cycle

  3. Compare change in androgen levels during the ovarian stimulation cycle [ Time Frame: Up to 2 weeks ]
    Androgen level data will be collected at baseline and after completion of the stimulation cycle

  4. Compare change in estrogen in follicular fluid [ Time Frame: Up to 2 weeks ]
    Estrogen levels in follicular fluid will be collected at baseline and after completion of the stimulation cycle

  5. Compare change in letrozole in follicular fluid [ Time Frame: Up to 2 weeks ]
    Letrozole levels in follicular fluid will be collected at baseline and after completion of the stimulation cycle

  6. Compare change in tamoxifen in follicular fluid [ Time Frame: Up to 2 weeks ]
    Tamoxifen levels in follicular fluid will be collected at baseline and after completion of the stimulation cycle

  7. Compare duration of stimulation (days) and total gonadotropin dose [ Time Frame: Up to 2 weeks ]
  8. Number if competent oocytes on day 3 of embryo culture [ Time Frame: Up to 2 weeks ]
    To assess embryo quality, if applicable, on day 3 of embryo culture, a measure of the developmental competence of the oocytes.

  9. Number if competent oocytes on day 5 of embryo culture [ Time Frame: Up to 2 weeks ]
    To assess embryo quality, if applicable, on day 5 of embryo culture, a measure of the developmental competence of the oocytes.



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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 Criteria:

  • 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

Exclusion Criteria:

  • 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
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Contact: Ange Wang, MD 415-353-7475 Ange.Wang@ucsf.edu

Locations
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United States, California
University of California at San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Ange Wang, M.D.    415-353-7475    Ange.Wang@ucsf.edu   
Principal Investigator: Mitchell Rosen, M.D.         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Mitchell Rosen, MD University of California, San Francisco
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03011684    
Other Study ID Numbers: TALES Trial
NCI-2017-01809 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
16751 ( Other Identifier: University of California, San Francisco )
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of California, San Francisco:
Fertility Preservation
Breast Cancer
Additional relevant MeSH terms:
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Infertility
Tamoxifen
Letrozole
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
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents