Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial

ConditionInfertility
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of California, San Francisco

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Tamoxifen
  • Letrozole

Treatment groups

309 Participants
are divided into 3 treatment groups