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Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial

RECRUITINGPhase 3Sponsored by University of California, San Francisco
Actively Recruiting
PhasePhase 3
SponsorUniversity of California, San Francisco
Started2016-07-21
Est. completion2026-03-31
Eligibility
Age18 Years – 50 Years
SexFEMALE
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 18 Years – 50 YearsSex: FEMALEHealthy volunteers accepted
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

Conditions3

Breast CancerCancerInfertility

Locations1 site

University of California at San Francisco
San Francisco, California, 94143
Rebecca Wong415-353-4305Rebecca.Wong@ucsf.edu

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