Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial

Who is this study for? Patients with Breast Cancer, Infertility
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California at San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Rebecca Wong
Rebecca.Wong@ucsf.edu
415-353-4305
Time Frame
Start Date: 2016-07-21
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 309
Treatments
Experimental: Randomized ER Positive Participants (Letrozole)
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.
Experimental: Randomized ER Positive Participants (Tamoxifen)
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
No_intervention: ER Negative (ER-) Participants
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.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov