Ovarian Simulation and Tamoxifen or Letrozole in Fertility Preservation in Patients with Breast Cancer, TALES Study
- New breast cancer diagnosis
- Has not yet begun chemotherapy
- Desires to undergo ovarian stimulation and oocyte retrieval prior to cancer treatment
- 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
- 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
I. To determine if the assigned stimulation regimen will result in a difference in mature (meiosis II) oocyte yield in patients with breast cancer who undergo ovarian stimulation for fertility preservation.
I. To compare estrogen, progesterone, and androgen levels during the ovarian stimulation cycle.
II. To compare estrogen, letrozole, and tamoxifen levels in follicular fluid.
III. To compare duration of stimulation (days) and total gonadotropin dose (international units of follicle stimulating hormone [FSH]).
IV. To assess embryo quality, if applicable, on day 3 and day 5 of embryo culture, a measure of the developmental competence of the oocytes.
I. To compare clinical pregnancy rates when cryopreserved tissue is eventually utilized among patients from the assigned stimulation regimens.
OUTLINE: Patients with estrogen receptor positive are randomized to Groups I or II. Patients with estrogen receptor negative are assigned to Group III.
GROUP I: Patients undergo ovarian stimulation with gonadotrophin subcutaneously (SC) and receive tamoxifen citrate orally (PO) daily until the day of egg retrieval.
GROUP II: Patients undergo ovarian stimulation with gonadotrophin SC and receive letrozole PO daily until the day of egg retrieval.
GROUP III: Patients undergo ovarian stimulation with gonadotrophin SC daily until the day of egg retrieval.
Trial Phase Phase IV
Trial Type Supportive care
University of California San Francisco
Mitchell P. Rosen
- Primary ID 16751
- Secondary IDs NCI-2017-01809, 15-17818
- Clinicaltrials.gov ID NCT03011684