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

NCT06075953 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: RECAST-DCIS
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 27

Brief 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.

Conditions

Ductal Carcinoma in Situ

Keywords

active surveillance; hormone therapy; endocrine therapy

Outcome Measures

Primary Outcomes (1)

• Patients remaining on active surveillance at 7 months

  Fraction of patients remaining on active surveillance at 7 months compared to control

  7 months

Secondary Outcomes (8)

• To determine whether novel endocrine therapy increases the fraction of patients who will be suitable for long-term active surveillance as measured by the fraction of patients deemed to be low-risk for invasive cancer at 6 months compared to control

  6 months

• To determine whether novel endocrine therapy increases the fraction of patients who will be suitable for long-term active surveillance as measured by the fraction of patients deemed to be low-risk for invasive cancer at 3 months compared to control

  3 months

• Associate rate of progression to Invasive Ductal Carcinoma (IDC) with risk categorization after 6 months of treatment at 3 years

  3 years

• To assess the QoL impact of novel endocrine therapy compared to tamoxifen or Aromatase inhibitor (Ai) at standard or low dose using PROMIS and the FACT-ES and FACT-GP5 composite score compared to control

  6 months

• For those with an identified lesion on MRI imaging, determine whether neoadjuvant endocrine therapy decreases lesion volume (qualitative, quantitative) and whether that corresponds to the biologic type of Ductal cell carcinoma In Situ (DCIS)

  6 months

Other Outcomes (2)

• Assess Germ Line polygenic risk: assess correlation of detectable mutations with endocrine response and qualification for active surveillance at 7 months

  7 months

• To evaluate outcomes stratified by immune and molecular subtype based upon multiplex immuno histochemistry (IHC) clustering analysis, and RPS expression array profiling

  7 months

Study Arms (4)

chemoprevention therapy per investigator choice

ACTIVE COMPARATOR

For premenopausal women: 20 mg tamoxifen orally daily (standard dose) or 10 mg every other day (low dose). For postmenopausal women: standard oral doses of AI of choice: exemestane 25 mg daily, letrozole 2.5 mg daily, or anastrozole 1 mg daily; or reduced exemestane dosing: 25 mg 3X per week orally. 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. There is active follow up with MRI at baseline, 3 months, 6 months after treatment initiation, and every 6 months alternating MRI and mammogram for up to 5 years. Participants may continue treatment for up to 5 years.

Drug: Tamoxifen; Drug: Exemestane; Drug: Letrozole; Drug: Anastrazole

Testosterone + Anastrazole (T+Ai)

EXPERIMENTAL

White solid pellet for subcutaneous insertion consisting of 100mg Testosterone and 4mg Anastrazole, an aromatase inhibitor. A cylindrical pellet (4.5mm diameter, 6.35mm diameter) is inserted subcutaneously in the upper outer gluteal region or iliac fossa every 3 months, with treatment up to 36 months. There is active follow up with MRI at baseline, 3 months, 6 months after treatment initiation, and every 6 months alternating MRI and mammogram for up to 5 years. Participants are followed for an additional 5 years.

Drug: Testosterone + Anastrazole

Elacestrant

EXPERIMENTAL

Selective estrogen receptor degrader, Standard dose: 400mg PO with food once daily for treatment up to 36 months. Dose reduction of Elacestrant by up to 2 dose levels permitted depending on toxicity; 400 mg to 300 mg then 300 mg to 200 mg Participants requiring more than 2 dose reductions must discontinue treatment For patients on this arm there is active follow up with MRI at baseline, 3 months, 6 months after treatment initiation, and every 6 months alternating MRI and mammogram for up to 5 years. Participants are followed by for an additional 5 years.

Drug: Elacestrant

Endoxifen

EXPERIMENTAL

(Z)-endoxifen is the most active metabolite of the selective estrogen receptor modulator (SERM), tamoxifen. Standard dose: 10mg PO delayed release capsule of z-endoxifen once daily for treatment up to 36 months. same time with a glass of water either 1 hour before a meal or 2 hours after a meal and should not take with alcohol. For patients on this arm there is active follow up with MRI at baseline, 3 months, 6 months after treatment initiation, and every 6 months alternating MRI and mammogram for up to 5 years. Participants are followed for an additional 5 years.

Drug: Z-endoxifen

Interventions

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

chemoprevention therapy per investigator choice

Letrozole DRUG

For postmenopausal women: standard oral doses of AI of choice: letrozole 2.5 mg daily.

chemoprevention therapy per investigator choice

Anastrazole DRUG

For postmenopausal women: standard oral doses of AI of choice: anastrozole 1 mg daily.

chemoprevention therapy per investigator choice

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.

Also known as: T+Ai

Testosterone + Anastrazole (T+Ai)

Elacestrant DRUG

Investigational drug. Both pre- and post- menopausal subjects. Elacestrant 400mg PO with food once daily up to 36 months.

Elacestrant

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.

Endoxifen

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.

chemoprevention therapy per investigator choice

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

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

Sponsors & Collaborators

• QuantumLeap Healthcare Collaborative: lead

Study Sites (27)

Berkeley Outpatient Center

Berkeley, California, 94158, United States

RECRUITING

City of Hope -Duarte Cancer Center

Duarte, California, 91010, United States

RECRUITING

City of Hope - Lennar Foundation Cancer Center

Irvine, California, 92618, United States

RECRUITING

UCLA

Los Angeles, California, 90095, United States

RECRUITING

UCSF

San Francisco, California, 94158, United States

RECRUITING

City of Hope

South Pasadena, California, 91030, United States

RECRUITING

John Muir Health

Walnut Creek, California, 94598, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Maple Grove Cancer Center

Maple Grove, Minnesota, 55369, United States

RECRUITING

Hennepin Healthcare -Minneapolis

Minneapolis, Minnesota, 55404, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Health Partners - Frauenshuh Cancer Center

Saint Louis Park, Minnesota, 55426, United States

RECRUITING

Health Partners - Regions Hospital

Saint Paul, Minnesota, 55101, United States

RECRUITING

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

RECRUITING

Mount Sinai Union Square

New York, New York, 10003, United States

RECRUITING

Mount Sinai Chelsea

New York, New York, 10011, United States

RECRUITING

Mount Sinai West

New York, New York, 10019, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Duke Cancer Institute

Durham, North Carolina, 27710, United States

RECRUITING

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

ACTIVE NOT RECRUITING

Paoli Hospital

Paoli, Pennsylvania, 19301, United States

ACTIVE NOT RECRUITING

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

ACTIVE NOT RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Interventions

Tamoxifen; exemestane; Letrozole; Anastrozole; Testosterone; elacestrant; 4-hydroxy-N-desmethyltamoxifen

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Laura Esserman, MD, MBA

  University of California, San Fancisco - Department of Surgery

  PRINCIPAL INVESTIGATOR

• (Co-PI) Kelly Hewitt, MD, FACS

  Huntsman Cancer Institute at the University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim Nelson, RN

CONTACT

+1 (888) 343-9922; k.nelson@qlhc.org

Tammy Neseth, MA, CCRP

CONTACT

+1 (507) 269-8060; t.neseth@qlhc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RECAST-DCIS is an open-label, multi-site platform study designed to offer women with Ductal cell Carcinoma In Situ (DCIS) 6 months of neo-adjuvant exposure to endocrine therapy with the intent of determining their suitability for long-term active surveillance without surgery.

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 10, 2023
• Study Start: February 17, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2033
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (27)