400
Participants
Start Date
February 17, 2024
Primary Completion Date
November 30, 2028
Study Completion Date
November 30, 2033
Tamoxifen
"For premenopausal women: 20 mg tamoxifen orally daily (standard dose) or 10 mg every other day (low dose).~For postmenopausal women who are not tolerating an AI, investigators can change them to the low dose (10 mg every other day) or standard dose (20 mg) of tamoxifen."
Exemestane
For postmenopausal women: standard oral doses of AI of choice: exemestane 25 mg daily, or reduced exemestane dosing: 25 mg 3 times per week orally
Letrozole
For postmenopausal women: standard oral doses of AI of choice: letrozole 2.5 mg daily.
Anastrazole
For postmenopausal women: standard oral doses of AI of choice: anastrozole 1 mg daily.
Testosterone + Anastrazole
Investigational drug. Both pre- and post- menopausal subjects. 100mg testosterone in combination with 4mg anastrazole administered subcutaneously every 3 months for up to 3 years.
Elacestrant
Investigational drug. Both pre- and post- menopausal subjects. Elacestrant 400mg PO with food once daily up to 36 months.
Z-endoxifen
Investigational drug. Both pre- and post- menopausal subjects. (z)-endoxifen 10mg delayed release capsule 1 hour before a meal or 2 hours after a meal once daily for up to 36 months.
RECRUITING
Mount Sinai Union Square, New York
RECRUITING
Mount Sinai Chelsea, New York
RECRUITING
Mount Sinai West, New York
RECRUITING
Icahn School of Medicine at Mount Sinai, New York
RECRUITING
Bryn Mawr Hospital, Bryn Mawr
RECRUITING
Lankenau Medical Center, Wynnewood
RECRUITING
Paoli Hospital, Paoli
RECRUITING
Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem
RECRUITING
Winship Cancer Institute, Emory University, Atlanta
RECRUITING
Vanderbilt University Medical Center, Nashville
RECRUITING
Hennepin Healthcare -Minneapolis, Minneapolis
RECRUITING
University of Chicago Medical Center, Chicago
RECRUITING
Huntsman Cancer Institute, Salt Lake City
RECRUITING
Berkeley Outpatient Center, Berkeley
RECRUITING
UCSF, San Francisco
RECRUITING
John Muir Health, Walnut Creek
RECRUITING
Englewood Hospital and Medical Center, Englewood
QuantumLeap Healthcare Collaborative
OTHER