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DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
Trial Status: active
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.
Inclusion 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
Additional locations may be listed on ClinicalTrials.gov for NCT06075953.
