Ductal Carcinoma in SituPhase 2NCT06075953
DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
A Phase 2 study testing Tamoxifen, Exemestane and Letrozole in people with Ductal Carcinoma in Situ, run by QuantumLeap Healthcare Collaborative at 30 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ductal Carcinoma in Situ
- What is being tested?
- Tamoxifen, Exemestane and Letrozole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 30 sitesUnited States
- Study dates
- 17 Feb 2024to Nov 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, at least 18 years old
- 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.
- 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
- 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.
- 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.
Show all 10Show fewer
- 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
- Negative urine or serum pregnancy test within 1 month of the start of trial treatment
- Controlled HIV positive patients are allowed as long as their current medication does not contraindicate the study's investigational agent
- Willingness and ability to provide tumor samples for research
Who cannot join
- Pregnant or actively breastfeeding women
- 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
- Invasive carcinoma or identification of a mass on MRI that is subsequently biopsied and found to be invasive cancer
- Co-enrollment in clinical trials of pharmacologic agents requiring an IND
- Ongoing treatment for DCIS other than what is specified in this protocol
- Uncontrolled intercurrent illness, including psychiatric conditions, that would limit compliance with study requirements
Show all 12Show fewer
- 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)
- Participants who are unable to swallow normally or unable to take tablets and capsules. Predictable poor compliance with oral treatment
- 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.
- Severe allergy or reaction history to MRI contrast.
- Participants currently undergoing or who have received treatment for another malignancy within the previous 6 months.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
United States30 sites, 27 recruiting
- Recruiting
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Winship Clinical Trials Office, 1-404-778-1868, winshipcto@emory.edu
Trisha Burrello, trisha.n.burrello@emory.edu
- Recruiting
Berkeley Outpatient Center
Berkeley, California, 94158
Niloufar Abdollahi, 415.476.3322, Niloufar.abdollahi@ucsf.edu
Dasha Peiris, 415-533-0141, Dasha.Peiris@ucsf.edu
- Active, not recruiting
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Vhenyse Encarnacion, vhenyse.encarnacion@bsd.uchicago.edu
Betty Fan, MD
- Recruiting
City of Hope -Duarte Cancer Center
Duarte, California, 91010
Mellissa Henry, RN, MSN, FNP-C, 626-713-8895, mehenry@coh.org
Jennifer Tseng, MD
- Recruiting
Duke Cancer Institute
Durham, North Carolina, 27710
Breast Cancer Study Team, 919-660-1278, breastcl@dm.duke.edu
Ton Wang, MD
- Recruiting
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
Kayla Williams, 201-894-3000 ext. 9786, kayla.williams@ehmchealth.org
Jennifer Marti, MD
- Recruiting
City of Hope - Lennar Foundation Cancer Center
Irvine, California, 92618
Mellissa Henry, RN, MSN, FNP-C, 626-713-8895, mehenry@coh.org
Jennifer Tseng, MD
- Recruiting
UCLA
Los Angeles, California, 90095
Sophia Quiroz, Clinical Research Coordinator, 310-794-0130, SQuiroz@mednet.ucla.edu
Mediget Teshome, MD
- Recruiting
Maple Grove Cancer Center
Maple Grove, Minnesota, 55369
Oncology Access Nurse, 612-624-2620, ccinfo@umn.edu
Jane Hui, MD
- Recruiting
Hennepin Healthcare -Minneapolis
Minneapolis, Minnesota, 55404
Hannah Merrill, 952-993-0996, hannah.merrill@parknicollet.com
Niki Hoese, 952-993-1585, nicole.hoese@parknicollet.com
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Oncology Access Nurse, 612-624-2620, ccinfo@umn.edu
Jane Hui, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Oncology nursing, 1-800-811-8480, cip@vumc.org
Jennifer Goodman, RN, BSN, 615.936.6825, jennifer.e.goodman@vumc.org
- Recruiting
Mount Sinai Union Square
New York, New York, 10003
Contact: Site Public Contact, 212-824-7309, CRSU@mssm.edu
Tara Balija, MD
- Recruiting
Mount Sinai Chelsea
New York, New York, 10011
Contact: Site Public Contact, 212-824-7309, CRSU@mssm.edu
Tara Balija, MD
- Recruiting
Mount Sinai West
New York, New York, 10019
Contact: Site Public Contact, 212-824-7309, CRSU@mssm.edu
Tara Balija, MD
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Contact: Site Public Contact, 212-824-7309, CRSU@mssm.edu
Tara Balija, MD
- Active, not recruiting
Paoli Hospital
Paoli, Pennsylvania, 19301
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Massey CTO Breast Team, 804-628-6430, masseyctbrst@vcu.edu
Kandace McGuire, MD
- Recruiting
Health Partners - Frauenshuh Cancer Center
Saint Louis Park, Minnesota, 55426
Hannah Merrill, 952-993-0996, hannah.merrill@parknicollet.com
Niki Hoese, 952-993-1585, nicole.hoese@parknicollet.com
- Recruiting
Health Partners - Regions Hospital
Saint Paul, Minnesota, 55101
Hannah Merrill, 952-993-0996, hannah.merrill@parknicollet.com
Niki Hoese, 952-993-1585, nicole.hoese@parknicollet.com
- Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Janna Espinosa, 801-585-0571, Janna.Espinosa@hci.utah.edu
Kirstyn Brownson, MD
- Recruiting
UCSF
San Francisco, California, 94158
Dasha Peiris, 415-533-0141, Dasha.Peiris@ucsf.edu
Jordan Jackson, MD
- Recruiting
City of Hope
South Pasadena, California, 91030
Mellissa Henry, RN, MSN, FNP-C, 626-713-8895, mehenry@coh.org
Jennifer Tseng, MD
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Neveen Abdo, Clinical Research Coordinator, 727-748-9345, Neveen.abdo@moffitt.org
Laura Kruper, MD
- Recruiting
Montefiore Medical Center (Hutchinson Campus Tower 1)
The Bronx, New York, 10461
Melissa Suarez, 718-920-6742, mesuarez@montefiore.org
Linda Castellanos, 718-920-6742, lcastellan@montefiore.org
- Recruiting
John Muir Health
Walnut Creek, California, 94598
Jen Johnson, Clinical Research Coordinator, 925-674-2580, Jen.Johnson@johnmuirhealth.com
Monica Eigelberger, MD
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Hiwot Guebre-Xabiher, Research Manager, 202-877-8839, Hiwot.Guebre-Xabiher@medstar.net
Marc Boisvert, MD
- Recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Brandy Baker and Lindsy Davis, RN, 336-716-8941 OR 336-716-6748, brandy.baker@advocatehealth.org, lindsey.davis@advocatehealth.org
Sydney McEntire, sydney.mcentire@advocatehealth.org
- Active, not recruiting
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
About this study
Official title: DCIS: RECAST Trial -Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: a Breast Cancer Prevention Pilot Study
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.
Read the 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.
- Conditions
- Ductal Carcinoma in Situ
- Keywords
- active surveillance, hormone therapy, endocrine therapy
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
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.
ExemestaneDrug
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
LetrozoleDrug
For postmenopausal women: standard oral doses of AI of choice: letrozole 2.5 mg daily.
AnastrazoleDrug
For postmenopausal women: standard oral doses of AI of choice: anastrozole 1 mg daily.
Testosterone + AnastrazoleDrug
Also called T+Ai
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.
ElacestrantDrug
Investigational drug. Both pre- and post- menopausal subjects. Elacestrant 400mg PO with food once daily up to 36 months.
Z-endoxifenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Z-endoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients remaining on active surveillance at 7 months
Fraction of patients remaining on active surveillance at 7 months compared to control
Measured: 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
Fraction of patients categorized as low risk by MRI after 6 months of treatment--Measured by cases demonstrating endocrine responsiveness (Determined based on lesion and background or lesion alone or lack of lesion and minimal background)
Measured: 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
Fraction of patients categorized as low risk by MRI after 3 months of treatment--Measured by cases demonstrating endocrine responsiveness (Determined based on lesion and background or lesion alone or lack of lesion and minimal background)
Measured: 3 months
Associate rate of progression to Invasive Ductal Carcinoma (IDC) with risk categorization after 6 months of treatment at 3 years
Correlation of low-risk categorization at 6 months with subsequent rate of Invasive Ductal Cell Carcinoma progression at 3 years
Measured: 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
Fraction of patients experiencing Minimum Important Difference in overall QOL measured by PROP-R statistics (PROMIS) and FACT-ES (functional assessment of cancer therapy- endocrine symptoms) and FACT-GP5, a quality of life (QoL) assessment)
Measured: 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)
Rate of reduction in focal lesions (mass and non-mass enhancement (NME) at 6 months and Rate of reduction in focal lesions using automated Functional Tumor Volume
Measured: 6 months
To determine whether neoadjuvant endocrine therapy decreases automated background parenchymal enhancement (BPE and automated MRI density compared to Ai and Tamoxifen
% with contralateral reduction in qualitative and automated BPE and % reduction in contralateral breast density
Measured: 6 months
Determine adherence to active surveillance protocol
Time to discontinuation of therapy (Tolerability of therapy) will be measured, and Adherence rates on each regimen, as well as PROP-R, FACT-ES and FACT-GP5 score on each regimen will be measured. These assessments will be combined to evaluate efficacy and toxicity using a novel clinical benefit index.
Measured: 5 years
Change in artificial intelligence predicted risk based on mammography
Correlation of BPE change with agent and compare to quantitative imaging density
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start17 Feb 2024
- Primary completionNov 2028 (estimated)
- Study completionNov 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Carcinoma in SituStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- QuantumLeap Healthcare Collaborative
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Esserman, MD, MBA, Principal investigator, University of California, San Fancisco - Department of Surgery(Co-PI) Kelly Hewitt, MD, FACS, Principal investigator, Huntsman Cancer Institute at the University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075953
- Sponsor's protocol ID
- RECAST-DCIS
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DCIS: RECAST Trial -Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: a Breast Cancer Prevention Pilot Study
- ClinicalTrials.gov ID
- NCT06075953
- Acronym / sponsor ID
- RECAST-DCIS
- Conditions
- Ductal Carcinoma in Situ
- Keywords
- active surveillance, hormone therapy, endocrine therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- QuantumLeap Healthcare CollaborativeUniversity, hospital or other
- Study start
- 17 Feb 2024 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2033 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| chemoprevention therapy per investigator choice | Active comparator | Drug: Tamoxifen, Drug: Exemestane, Drug: Letrozole, Drug: AnastrazoleFor 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. |
| Testosterone + Anastrazole (T+Ai) | Experimental | Drug: Testosterone + AnastrazoleWhite 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. |
| Elacestrant | Experimental | Drug: ElacestrantSelective 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. |
| Endoxifen | Experimental | Drug: Z-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female, at least 18 years old
- 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.
- 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
- 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.
Key exclusion criteria (12 listed)
- Pregnant or actively breastfeeding women
- 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
- Invasive carcinoma or identification of a mass on MRI that is subsequently biopsied and found to be invasive cancer
- Co-enrollment in clinical trials of pharmacologic agents requiring an IND
- Ongoing treatment for DCIS other than what is specified in this protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TamoxifenFor 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. | Drug | chemoprevention therapy per investigator choice |
| ExemestaneFor postmenopausal women: standard oral doses of AI of choice: exemestane 25 mg daily, or reduced exemestane dosing: 25 mg 3 times per week orally | Drug | chemoprevention therapy per investigator choice |
| LetrozoleFor postmenopausal women: standard oral doses of AI of choice: letrozole 2.5 mg daily. | Drug | chemoprevention therapy per investigator choice |
| AnastrazoleFor postmenopausal women: standard oral doses of AI of choice: anastrozole 1 mg daily. | Drug | chemoprevention therapy per investigator choice |
| Testosterone + AnastrazoleAlso: T+AiInvestigational drug. Both pre- and post- menopausal subjects. 100mg testosterone in combination with 4mg anastrazole administered subcutaneously every 3 months for up to 3 years. | Drug | Testosterone + Anastrazole (T+Ai) |
| ElacestrantInvestigational drug. Both pre- and post- menopausal subjects. Elacestrant 400mg PO with food once daily up to 36 months. | Drug | Elacestrant |
| Z-endoxifenInvestigational 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. | Drug | Endoxifen |
Primary outcome
Patients remaining on active surveillance at 7 months
Time frame: 7 months
Fraction of patients remaining on active surveillance at 7 months compared to control
8 secondary outcomes
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
Time frame: 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
Time frame: 3 months
Associate rate of progression to Invasive Ductal Carcinoma (IDC) with risk categorization after 6 months of treatment at 3 years
Time frame: 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
Time frame: 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)
Time frame: 6 months
To determine whether neoadjuvant endocrine therapy decreases automated background parenchymal enhancement (BPE and automated MRI density compared to Ai and Tamoxifen
Time frame: 6 months
Determine adherence to active surveillance protocol
Time frame: 5 years
Change in artificial intelligence predicted risk based on mammography
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Ductal Carcinoma in Situ
RecruitingObservational study
Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study
Mastectomy, Breast Neoplasm Malignant Primary
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Not yet recruiting
Addressing Financial Hardship in AYA Cancer Survivors Through the Use of the New LIFT UP Intervention
Breast Ductal Carcinoma In Situ, Hematopoietic and Lymphatic System Neoplasm
Active, not recruitingPhase 3
Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma
Active, not recruiting
Intraoperative Radiation Therapy (IORT) in DCIS
Breast Cancer, Ductal Carcinoma in Situ
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Esserman, MD, MBA principal investigator
University of California, San Fancisco - Department of Surgery
(Co-PI) Kelly Hewitt, MD, FACS principal investigator
Huntsman Cancer Institute at the University of Utah
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamoxifen, Exemestane and Letrozole in people with Ductal Carcinoma in Situ, run by QuantumLeap Healthcare Collaborative at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kim Nelson, RN (+1 (888) 343-9922 ext. 343, k.nelson@qlhc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients remaining on active surveillance at 7 months (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.