Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT03011684
Phase
PHASE3
Status
Recruiting
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Conditions

  • Infertility

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Tamoxifen — DRUG
    Given orally
  • Letrozole — DRUG
    Given orally

Study Details

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.

Key Dates

Start date
Jul 21, 2016
Status verified
Jun 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
309 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Mature Oocyte Yield [ Time Frame: Up to 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California at San FranciscoSan FranciscoCalifornia94143
Rebecca Wong
[email protected]
415-353-4305
Mitchell Rosen, M.D. (PRINCIPAL_INVESTIGATOR)

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