Actively Recruiting
DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
Led by QuantumLeap Healthcare Collaborative · Updated on 2026-05-11
400
Participants Needed
27
Research Sites
506 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, at least 18 years old
- Previous diagnosis of hormone receptor positive DCIS (at least 50% ER or PR) with or without microinvasion
- Patients with hormone positive DCIS who had surgery with positive margins not re-excised
- At least 4-6 weeks washout if previously received endocrine therapy before screening MRI
- Bilateral mammogram within 6 months or diagnostic unilateral mammogram within 12 months prior to treatment
- MRI on approved scanner within 2 months before treatment
- Normal or clinically acceptable CBC, CMP, and lipid panel within 1 year before treatment
- Negative urine or serum pregnancy test within 1 month before treatment
- Controlled HIV positive patients allowed if medications do not conflict with study drugs
- Willing and able to provide tumor samples for research
You will not qualify if you...
- Pregnant or actively breastfeeding women
- Allergic reactions to similar compounds as study drugs
- Presence of invasive carcinoma or MRI-detected mass confirmed as invasive cancer
- Participation in other clinical trials with investigational drugs
- Ongoing treatment for DCIS outside of this study protocol
- Uncontrolled illnesses or psychiatric conditions limiting study compliance
- Gastrointestinal disorders affecting drug absorption, including active inflammatory bowel disease, chronic diarrhea, active hepatitis, cirrhosis, short bowel syndrome, or major upper GI surgery
- Inability to swallow tablets or capsules or expected poor compliance with oral treatment
AI-Screening
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Trial Site Locations
Total: 27 locations
1
Berkeley Outpatient Center
Berkeley, California, United States, 94158
Actively Recruiting
2
City of Hope -Duarte Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
3
City of Hope - Lennar Foundation Cancer Center
Irvine, California, United States, 92618
Actively Recruiting
4
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
5
UCSF
San Francisco, California, United States, 94158
Actively Recruiting
6
City of Hope
South Pasadena, California, United States, 91030
Actively Recruiting
7
John Muir Health
Walnut Creek, California, United States, 94598
Actively Recruiting
8
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
9
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
10
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
11
Maple Grove Cancer Center
Maple Grove, Minnesota, United States, 55369
Actively Recruiting
12
Hennepin Healthcare -Minneapolis
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
13
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
14
Health Partners - Frauenshuh Cancer Center
Saint Louis Park, Minnesota, United States, 55426
Actively Recruiting
15
Health Partners - Regions Hospital
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
16
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
Actively Recruiting
17
Mount Sinai Union Square
New York, New York, United States, 10003
Actively Recruiting
18
Mount Sinai Chelsea
New York, New York, United States, 10011
Actively Recruiting
19
Mount Sinai West
New York, New York, United States, 10019
Actively Recruiting
20
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
21
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Actively Recruiting
22
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
23
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Active, Not Recruiting
24
Paoli Hospital
Paoli, Pennsylvania, United States, 19301
Active, Not Recruiting
25
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
Active, Not Recruiting
26
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
27
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
K
Kim Nelson, RN
CONTACT
T
Tammy Neseth, MA, CCRP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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