OncoMatch/Clinical Trials/NCT06075953
DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
Is NCT06075953 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for ductal carcinoma in situ.
Treatment: Tamoxifen · Exemestane · Letrozole · Anastrazole · Testosterone + Anastrazole · Elacestrant · Z-endoxifen — 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.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: ESR1 overexpression (at least 50% ER) (at least 50%)
at least 50% ER
Required: PR (PGR) overexpression (at least 50% PR) (at least 50%)
at least 50% PR
Lab requirements
Blood counts
CBC w/ diff 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
Kidney function
CMP 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
Liver function
CMP 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
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Berkeley Outpatient Center · Berkeley, California
- City of Hope -Duarte Cancer Center · Duarte, California
- City of Hope - Lennar Foundation Cancer Center · Irvine, California
- UCLA · Los Angeles, California
- UCSF · San Francisco, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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