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.
Additional locations may be listed on ClinicalTrials.gov for NCT03011684.
Locations matching your search criteria
United States
California
San Francisco
University of California San FranciscoStatus: Active
Contact: Mitchell P. Rosen
Phone: 415-885-7870
UCSF Medical Center-Mount ZionStatus: 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 PhasePhase IV
Trial Typesupportive care
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorMitchell P. Rosen
