RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: QuantumLeap Healthcare Collaborative • ClinicalTrials.gov ID: NCT06075953

Registry updated: 2026-09-28

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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. 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.

Interventions

Tamoxifen (Drug)
For premenopausal women: 20 mg tamoxifen orally daily (standard dose) or 10 mg every other day (low dose). For postmenopausal women who are not tolerating an AI, investigators can change them to the low dose (10 mg every other day) or standard dose (20 mg) of tamoxifen.
Exemestane (Drug)
For postmenopausal women: standard oral doses of AI of choice: exemestane 25 mg daily, or reduced exemestane dosing: 25 mg 3 times per week orally
Letrozole (Drug)
For postmenopausal women: standard oral doses of AI of choice: letrozole 2.5 mg daily.
Anastrazole (Drug)
For postmenopausal women: standard oral doses of AI of choice: anastrozole 1 mg daily.
Testosterone + Anastrazole (Drug)
Investigational drug. Both pre- and post- menopausal subjects. 100mg testosterone in combination with 4mg anastrazole administered subcutaneously every 3 months for up to 3 years.
Elacestrant (Drug)
Investigational drug. Both pre- and post- menopausal subjects. Elacestrant 400mg PO with food once daily up to 36 months.
Z-endoxifen (Drug)
Investigational drug. Both pre- and post- menopausal subjects. (z)-endoxifen 10mg delayed release capsule 1 hour before a meal or 2 hours after a meal once daily for up to 36 months.

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 * 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 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 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.

Conditions

Ductal Carcinoma in Situ

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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