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NCT06075953PHASE2Recruiting

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

QuantumLeap Healthcare Collaborative

Start Date

2/17/2024

Completion Date

11/1/2033

Summary

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.

Detailed 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. 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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Tamoxifen

DRUG

Exemestane

DRUG

Letrozole

DRUG

Anastrazole

DRUG

Testosterone + Anastrazole

DRUG

Elacestrant

DRUG

Z-endoxifen

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Conditions

Ductal Carcinoma in Situ

Locations

Berkeley Outpatient Center

Berkeley, California 94158

United States

City of Hope -Duarte Cancer Center

Duarte, California 91010

United States

City of Hope - Lennar Foundation Cancer Center

Irvine, California 92618

United States

UCLA

Los Angeles, California 90095

United States

UCSF

San Francisco, California 94158

United States

City of Hope

South Pasadena, California 91030

United States

John Muir Health

Walnut Creek, California 94598

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

United States

University of Chicago Medical Center

Chicago, Illinois 60637

United States

Maple Grove Cancer Center

Maple Grove, Minnesota 55369

United States

Hennepin Healthcare -Minneapolis

Minneapolis, Minnesota 55404

United States

University of Minnesota

Minneapolis, Minnesota 55455

United States

Health Partners - Frauenshuh Cancer Center

Saint Louis Park, Minnesota 55426

United States

Health Partners - Regions Hospital

Saint Paul, Minnesota 55101

United States

Englewood Hospital and Medical Center

Englewood, New Jersey 07631

United States

Mount Sinai Union Square

New York, New York 10003

United States

Mount Sinai Chelsea

New York, New York 10011

United States

Mount Sinai West

New York, New York 10019

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Duke Cancer Institute

Durham, North Carolina 27710

United States

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina 27157

United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania 19010

United States

Paoli Hospital

Paoli, Pennsylvania 19301

United States

Lankenau Medical Center

Wynnewood, Pennsylvania 19096

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States

Virginia Commonwealth University

Richmond, Virginia 23298

United States