RecruitingPhase 3NCT03011684

Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial

Sponsor

University of California, San Francisco

Enrollment

309 participants

Start Date

Jul 21, 2016

Study Type

INTERVENTIONAL

Conditions

Infertility

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

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria4

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 Criteria7

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