DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
Start Date
2/17/2024
Completion Date
11/1/2033
Summary
The goal of this trial is to see if active surveillance monitoring and hormonal therapy in patients diagnosed with ductal cell carcinoma in situ (DCIS), an early stage of breast cancer, can be an effective management of the disease. Participants will be asked to receive control hormonal therapy or an investigational hormonal therapy treatment. Participants will be asked to return for evaluation with MRI at three months and six months. Depending on the evaluation participants will have the option to continue on the treatment. If the evaluation suggests surgery is recommended, the participant will discontinue the study treatment and will undergo surgery. In addition to the treatment and MRI evaluation, participants will be asked to provide blood sample to understand their immune status, provide saliva sample for genetic testing, provide the study with a portion of the tissue or slides generated from tissue removed during surgery performed as part of their standard of care.
Detailed Description
The goal of this trial is to see if active surveillance monitoring and hormonal therapy in patients diagnosed with Ductal cell Carcinoma In Situ (DCIS), an early stage of breast cancer, can be an effective management of the disease. The current management of most patients with DCIS involves surgical intervention with or without radiation, similar to more aggressive breast cancers. These treatments can come with some significant health effects.The main question this study aims to answer is: to determine whether novel endocrine therapy increases the fraction of patients who will be suitable for long-term active surveillance. Participants will be asked to take one of three investigational study medication (z-Elacestrant, Testosterone + Anastrazole, or Endoxifen) or receive control hormonal therapy (Tamoxifen or an aromatase inhibitor), depending on the treatment to which they have been randomized. Participants will be asked to return for evaluation with MRI at three months and six months. Depending on the evaluation, participants will have the option to continue on the treatment, with follow up evaluations of Mammogram and MRI at 6 month intervals. If the evaluation suggests surgery is recommended, the participant will discontinue the study treatment and will undergo surgery. In addition to the treatment and MRI evaluation, participants will be asked to: * Provide blood sample to understand their immune status * Provide saliva sample for genetic testing * Provide the study with a portion of the tissue or slides generated from tissue removed during surgery performed as part of their standard of care. Participants will be followed annually for 10 years.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Tamoxifen
Exemestane
Letrozole
Anastrazole
Testosterone + Anastrazole
Elacestrant
Z-endoxifen
Conditions
Locations
Berkeley Outpatient Center
Berkeley, California 94158
United States
City of Hope -Duarte Cancer Center
Duarte, California 91010
United States
City of Hope - Lennar Foundation Cancer Center
Irvine, California 92618
United States
UCLA
Los Angeles, California 90095
United States
UCSF
San Francisco, California 94158
United States
City of Hope
South Pasadena, California 91030
United States
John Muir Health
Walnut Creek, California 94598
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Winship Cancer Institute, Emory University
Atlanta, Georgia 30322
United States
University of Chicago Medical Center
Chicago, Illinois 60637
United States
Maple Grove Cancer Center
Maple Grove, Minnesota 55369
United States
Hennepin Healthcare -Minneapolis
Minneapolis, Minnesota 55404
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
Health Partners - Frauenshuh Cancer Center
Saint Louis Park, Minnesota 55426
United States
Health Partners - Regions Hospital
Saint Paul, Minnesota 55101
United States
Englewood Hospital and Medical Center
Englewood, New Jersey 07631
United States
Mount Sinai Union Square
New York, New York 10003
United States
Mount Sinai Chelsea
New York, New York 10011
United States
Mount Sinai West
New York, New York 10019
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Duke Cancer Institute
Durham, North Carolina 27710
United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina 27157
United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania 19010
United States
Paoli Hospital
Paoli, Pennsylvania 19301
United States
Lankenau Medical Center
Wynnewood, Pennsylvania 19096
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
Virginia Commonwealth University
Richmond, Virginia 23298
United States