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

Recruiting now · Phase 2

Conditions studied: Ductal Carcinoma in Situ

In brief

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.

Key facts

Study ID

NCT06075953

Run by

QuantumLeap Healthcare Collaborative

People needed

400

Starts

2024-02-17

Expected to finish

2033-11-01

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Patients with a diagnosis of hormone positive DCIS who have undergone surgery with positive margins that have not been re-excised are candidates to enroll in the trial.
• C. Patients who have previously received endocrine therapy should have a washout period of at minimum 4-6 weeks prior to the screening MRI on the RECAST-DCIS trial
• D. Bilateral mammogram performed within up to 6 months (180 days) of the start of trial treatment may be used for screening evaluation. If a bilateral mammogram has been performed within 1 year (12 months) of the start of trial treatment, then a diagnostic unilateral mammogram within 6 months (180 days) of the start of trial treatment will be acceptable for screening evaluation.
• E. MRI performed on an I SPY (RECAST) approved scanner within 2 months (60 days) of the start of trial treatment for lesion evaluation may be used for screening 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

You may not qualify if…

• 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
• I. Participants with substantial MRI artifacts (e.g., related to localizer sequences, cardiac devices such as pacemakers, or other hardware) that render the lesion non-evaluable.
• J. Severe allergy or reaction history to MRI contrast.
• K. Participants currently undergoing or who have received treatment for another malignancy within the previous 6 months.

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)
• City of Hope -Duarte Cancer Center — Duarte, California, United States (enrolling)
• City of Hope - Lennar Foundation Cancer Center — Irvine, California, United States (enrolling)
• UCLA — Los Angeles, California, United States (enrolling)
• UCSF — San Francisco, California, United States (enrolling)
• City of Hope — South Pasadena, California, United States (enrolling)
• John Muir Health — Walnut Creek, California, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States (enrolling)
• University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• Maple Grove Cancer Center — Maple Grove, Minnesota, United States (enrolling)
• Hennepin Healthcare -Minneapolis — Minneapolis, Minnesota, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Health Partners - Frauenshuh Cancer Center — Saint Louis Park, Minnesota, United States (enrolling)
• Health Partners - Regions Hospital — Saint Paul, Minnesota, United States (enrolling)
• Englewood Hospital and Medical Center — Englewood, New Jersey, United States (enrolling)
• Mount Sinai Union Square — New York, New York, United States (enrolling)
• Mount Sinai Chelsea — New York, New York, United States (enrolling)
• Mount Sinai West — New York, New York, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• Duke Cancer Institute — Durham, North Carolina, United States (enrolling)
• Atrium Health Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Huntsman Cancer Institute — Salt Lake City, Utah, United States (enrolling)
• Berkeley Outpatient Center — Berkeley, California, United States (enrolling)

Full record on ClinicalTrials.gov

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