DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
NCT ID: NCT06075953
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
400 participants
INTERVENTIONAL
2024-02-17
2033-11-30
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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chemoprevention therapy per investigator choice
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.
Tamoxifen
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
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
For postmenopausal women: standard oral doses of AI of choice: letrozole 2.5 mg daily.
Anastrazole
For postmenopausal women: standard oral doses of AI of choice: anastrozole 1 mg daily.
Testosterone + Anastrazole (T+Ai)
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.
Testosterone + Anastrazole
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
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.
Elacestrant
Investigational drug. Both pre- and post- menopausal subjects. Elacestrant 400mg PO with food once daily up to 36 months.
Endoxifen
(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.
Z-endoxifen
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.
Interventions
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Tamoxifen
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
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
For postmenopausal women: standard oral doses of AI of choice: letrozole 2.5 mg daily.
Anastrazole
For postmenopausal women: standard oral doses of AI of choice: anastrozole 1 mg daily.
Testosterone + Anastrazole
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
Investigational drug. Both pre- and post- menopausal subjects. Elacestrant 400mg PO with food once daily up to 36 months.
Z-endoxifen
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
FEMALE
No
Sponsors
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QuantumLeap Healthcare Collaborative
OTHER
Responsible Party
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Principal Investigators
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Laura Esserman, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
University of California, San Fancisco - Department of Surgery
(Co-PI) Kelly Hewitt, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
Huntsman Cancer Institute at the University of Utah
Locations
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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
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
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
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
Countries
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Central Contacts
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Facility Contacts
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Brandy Baker and Lindsy Davis, RN
Role: primary
Other Identifiers
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RECAST-DCIS
Identifier Type: -
Identifier Source: org_study_id