Actively Recruiting
DCIS: RECAST Trial - Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment, a Breast Cancer Prevention Pilot Study
Led by QuantumLeap Healthcare Collaborative · Updated on 2026-05-22
400
Participants Needed
28
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether active surveillance combined with hormonal therapy can effectively manage ductal cell carcinoma in situ (DCIS), an early stage of breast cancer. This phase 2 trial aims to determine if novel endocrine therapies increase the number of patients suitable for long-term active surveillance, potentially reducing the need for surgery and radiation which can have significant health effects. Participants are randomly assigned to receive one of several hormonal treatments: standard or low-dose tamoxifen, aromatase inhibitors (exemestane, letrozole, or anastrozole), or investigational drugs including testosterone with anastrazole pellets, elacestrant, or z-endoxifen capsules. Treatments are given orally or via subcutaneous pellet insertion, with follow-up evaluations using MRI at baseline, 3 months, 6 months, and then every 6 months alternating with mammograms, for up to 5 years. Participants may continue treatment for up to 36 months or longer, with some followed annually for 10 years. Throughout the study, participants provide blood and saliva samples to assess immune status and genetics, and tissue samples from any surgeries performed as part of standard care. The main outcome measured is the number of patients remaining on active surveillance at 7 months. Secondary outcomes include risk reduction for invasive cancer, lesion changes on imaging, quality of life assessments, treatment adherence, and long-term monitoring of cancer progression over several years.
CONDITIONS
Brief 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% estrogen or progesterone receptor positive), with or without microinvasion
- Patients with hormone positive DCIS who have had surgery with positive margins not re-excised are eligible
- Minimum 4-6 week washout period from prior endocrine therapy before screening MRI
- Bilateral mammogram within 6 months or diagnostic unilateral mammogram within 1 year of trial treatment start
- MRI on approved scanner within 2 months of trial treatment start
- Normal blood tests (CBC with diff, CMP, lipid panel) within 1 year, or repeated within 60 days if abnormal but clinically acceptable
- Negative pregnancy test within 1 month of trial treatment start
- Controlled HIV positive patients allowed if medications do not conflict
- Willingness and ability to provide tumor samples for research
You will not qualify if you...
- Pregnant or actively breastfeeding women
- History of allergic reactions to similar compounds as study agents
- Presence of invasive carcinoma or mass on MRI confirmed as invasive cancer
- Participation in other clinical trials requiring investigational new drug applications
- Ongoing treatment for DCIS outside this protocol
- Uncontrolled illnesses including psychiatric conditions limiting compliance
- Medical history or active gastrointestinal disorders affecting drug absorption, including active hepatitis A, B, or C, cirrhosis, short bowel syndrome, or certain gastrointestinal surgeries
- Inability to swallow tablets or capsules normally
- Expected poor compliance with oral treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 36 months with imaging follow-up up to 5 years
Participants take one of several hormonal therapies or investigational drugs for management of DCIS. They will have evaluations with MRI at 3 months and 6 months to assess treatment response and suitability for continued active surveillance. Treatment may continue for up to 36 months with follow-up imaging every 6 months alternating between MRI and mammogram for up to 5 years.
MRI evaluations at baseline, 3 months, 6 months, then every 6 months alternating MRI and mammogram for up to 5 years
Duration - Up to 10 years
Participants are followed annually for up to 10 years to monitor long-term outcomes and adherence to the active surveillance protocol.
Annual visits for follow-up
Trial Site Locations
Total: 28 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
28
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
K
Kim Nelson, RN
T
Tammy Neseth, MA, CCRP
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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