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Ovarian Simulation and Tamoxifen or Letrozole in Fertility Preservation in Patients with Breast Cancer, TALES Study

Trial Status: Active

This randomized phase IV trial studies how well ovarian stimulation and tamoxifen or letrozole work in fertility preservation in patients with breast cancer. Ovarian stimulation uses medicines such as gonadotrophins to stimulate the ovaries to mature more eggs. Tamoxifen may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and blocks the effects of estrogen. Letrozole may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and lower the body's estrogen levels. It is now yet know whether giving ovarian stimulation with tamoxifen or letrozole may work better in amount of mature eggs being retrieved.

Inclusion Criteria

  • New breast cancer diagnosis
  • Has not yet begun chemotherapy
  • Desires to undergo ovarian stimulation and oocyte retrieval prior to cancer treatment

Exclusion Criteria

  • 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

California

San Francisco
UCSF Medical Center-Mount Zion
Status: ACTIVE
Contact: Mitchell P. Rosen
Phone: 415-885-7870
University of California San Francisco
Status: ACTIVE
Contact: Mitchell P. Rosen
Phone: 415-885-7870

PRIMARY OBJECTIVE:

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.

SECONDARY OBJECTIVES:

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.

EXPERIMENTAL OBJECTIVE:

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

Lead Organization
University of California San Francisco

Principal Investigator
Mitchell P. Rosen

  • Primary ID 16751
  • Secondary IDs NCI-2017-01809, 15-17818
  • Clinicaltrials.gov ID NCT03011684