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DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
NCT06075953 · QuantumLeap Healthcare Collaborative
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
DCIS: RECAST Trial -Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: a Breast Cancer Prevention Pilot Study
About this study
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
Inclusion Criteria:
A. Female, at least 18 years old
B. Previous diagnosis of HR+ DCIS (at least 50% ER or PR; biopsy will have been performed previously at diagnosis) with or without microinvasion
C. Patients who have previously received endocrine therapy should have a washout period of 4-6 weeks prior to the screening MRI on the RECAST-DCIS trial
D. Bilateral mammogram performed within up to 4 months (120 days) of the start of trial treatment may be used for screening evaluation
E. MRI performed within up to 2 months (60 days) of the start of trial treatment for lesion evaluation
F. CBC w/ diff, CMP, and Lipid Panel within normal limits within a year of the start of trial treatment. Abnormal labs to be repeated within 60 days prior to the start of trial treatment. Patients will be considered eligible for screening labs that are abnormal or out-of-range if the investigator has deemed the lab results not-clinically significant
G. Negative urine or serum pregnancy test within 1 month of the start of trial treatment
H. Controlled HIV positive patients are allowed as long as their current medication does not contraindicate the study's investigational agent
I. Willingness and ability to provide tumor samples for research
Exclusion Criteria:
A. Pregnant or actively breastfeeding women
B. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent based on review of the medical record and patient history
C. Invasive carcinoma or identification of a mass on MRI that is subsequently biopsied and found to be invasive cancer
D. Co-enrollment in clinical trials of pharmacologic agents requiring an IND
E. Ongoing treatment for DCIS other than what is specified in this protocol
F. Uncontrolled intercurrent illness, including psychiatric conditions, that would limit compliance with study requirements
G. Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of investigational agent and/or tamoxifen. Active inflammatory bowel disease or chronic diarrhea, known active hepatitis A/B/C\*, hepatic cirrhosis, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection or banding procedures
\*Active hepatitis, defined as: A (positive HA antigen or positive IgM); B (either positive HBs antigen or positive hepatitis B viral DNA test above the lower limit of detection of the assay); C (positive hepatitis C antibody result, and quantitative hepatitis C (HCV) ribonucleic acid (RNA) results greater than the lower limits of detection of the assay)
H. Participants who are unable to swallow normally or unable to take tablets and capsules. Predictable poor compliance with oral treatment
Study design
Enrollment target: 400 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-02-17
Estimated completion: 2033-11
Last updated: 2026-03-16
Interventions
Drug: TamoxifenDrug: ExemestaneDrug: LetrozoleDrug: AnastrazoleDrug: Testosterone + AnastrazoleDrug: ElacestrantDrug: Z-endoxifen
Primary outcomes
- • Patients remaining on active surveillance at 7 months (7 months)
Sponsor
QuantumLeap Healthcare Collaborative · other
Contacts & investigators
ContactKim Nelson, RN · contact · k.nelson@qlhc.org · +1 (888) 343-9922
ContactTammy Neseth, MA, CCRP · contact · t.neseth@qlhc.org · +1 (507) 269-8060
InvestigatorLaura Esserman, MD, MBA · principal_investigator, University of California, San Fancisco - Department of Surgery
Investigator(Co-PI) Kelly Hewitt, MD, FACS · principal_investigator, Huntsman Cancer Institute at the University of Utah
All locations (27)
Berkeley Outpatient CenterRecruiting
Berkeley, California, United States
City of Hope -Duarte Cancer CenterRecruiting
Duarte, California, United States
City of Hope - Lennar Foundation Cancer CenterRecruiting
Irvine, California, United States
UCLARecruiting
Los Angeles, California, United States
UCSFRecruiting
San Francisco, California, United States
City of HopeRecruiting
South Pasadena, California, United States
John Muir HealthRecruiting
Walnut Creek, California, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Winship Cancer Institute, Emory UniversityRecruiting
Atlanta, Georgia, United States
University of Chicago Medical CenterRecruiting
Chicago, Illinois, United States
Maple Grove Cancer CenterRecruiting
Maple Grove, Minnesota, United States
Hennepin Healthcare -MinneapolisRecruiting
Minneapolis, Minnesota, United States
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
Health Partners - Frauenshuh Cancer CenterRecruiting
Saint Louis Park, Minnesota, United States
Health Partners - Regions HospitalRecruiting
Saint Paul, Minnesota, United States
Englewood Hospital and Medical CenterRecruiting
Englewood, New Jersey, United States
Mount Sinai Union SquareRecruiting
New York, New York, United States
Mount Sinai ChelseaRecruiting
New York, New York, United States
Mount Sinai WestRecruiting
New York, New York, United States
Icahn School of Medicine at Mount SinaiRecruiting
New York, New York, United States
Duke Cancer InstituteRecruiting
Durham, North Carolina, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer CenterRecruiting
Winston-Salem, North Carolina, United States
Bryn Mawr HospitalRecruiting
Bryn Mawr, Pennsylvania, United States
Paoli HospitalRecruiting
Paoli, Pennsylvania, United States
Lankenau Medical CenterRecruiting
Wynnewood, Pennsylvania, United States
Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States
Huntsman Cancer InstituteRecruiting
Salt Lake City, Utah, United States