DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment

PHASE2RecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

February 17, 2024

Primary Completion Date

November 30, 2028

Study Completion Date

November 30, 2033

Conditions
Ductal Carcinoma in Situ
Interventions
DRUG

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."

DRUG

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

DRUG

Letrozole

For postmenopausal women: standard oral doses of AI of choice: letrozole 2.5 mg daily.

DRUG

Anastrazole

For postmenopausal women: standard oral doses of AI of choice: anastrozole 1 mg daily.

DRUG

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.

DRUG

Elacestrant

Investigational drug. Both pre- and post- menopausal subjects. Elacestrant 400mg PO with food once daily up to 36 months.

DRUG

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.

Trial Locations (17)

10003

RECRUITING

Mount Sinai Union Square, New York

10011

RECRUITING

Mount Sinai Chelsea, New York

10019

RECRUITING

Mount Sinai West, New York

10029

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

19010

RECRUITING

Bryn Mawr Hospital, Bryn Mawr

19096

RECRUITING

Lankenau Medical Center, Wynnewood

19301

RECRUITING

Paoli Hospital, Paoli

27157

RECRUITING

Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem

30322

RECRUITING

Winship Cancer Institute, Emory University, Atlanta

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

55404

RECRUITING

Hennepin Healthcare -Minneapolis, Minneapolis

60637

RECRUITING

University of Chicago Medical Center, Chicago

84112

RECRUITING

Huntsman Cancer Institute, Salt Lake City

94158

RECRUITING

Berkeley Outpatient Center, Berkeley

RECRUITING

UCSF, San Francisco

94598

RECRUITING

John Muir Health, Walnut Creek

07631

RECRUITING

Englewood Hospital and Medical Center, Englewood

All Listed Sponsors
lead

QuantumLeap Healthcare Collaborative

OTHER