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

July 17, 2026 updated by: QuantumLeap Healthcare Collaborative

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Tammy Neseth, MA, CCRP
  • Phone Number: +1 (507) 269-8060
  • Email: t.neseth@qlhc.org

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94158
        • Recruiting
        • Berkeley Outpatient Center
        • Contact:
        • Principal Investigator:
          • Jordan Jackson, MD
        • Contact:
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope -Duarte Cancer Center
        • Principal Investigator:
          • Jennifer Tseng, MD
        • Contact:
          • Mellissa Henry, RN, MSN, FNP-C
          • Phone Number: 626-713-8895
          • Email: mehenry@coh.org
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope - Lennar Foundation Cancer Center
        • Principal Investigator:
          • Jennifer Tseng, MD
        • Contact:
          • Mellissa Henry, RN, MSN, FNP-C
          • Phone Number: 626-713-8895
          • Email: mehenry@coh.org
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA
        • Contact:
        • Principal Investigator:
          • Mediget Teshome, MD
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF
        • Principal Investigator:
          • Jordan Jackson, MD
        • Contact:
      • South Pasadena, California, United States, 91030
        • Recruiting
        • City of Hope
        • Principal Investigator:
          • Jennifer Tseng, MD
        • Contact:
          • Mellissa Henry, RN, MSN, FNP-C
          • Phone Number: 626-713-8895
          • Email: mehenry@coh.org
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • John Muir Health
        • Contact:
        • Principal Investigator:
          • Monica Eigelberger, MD
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
        • Principal Investigator:
          • Laura Kruper, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute, Emory University
        • Principal Investigator:
          • Clara Farley, MD
        • Contact:
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Minnesota
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Maple Grove Cancer Center
        • Contact:
          • Oncology Access Nurse
          • Phone Number: 612-624-2620
          • Email: ccinfo@umn.edu
        • Principal Investigator:
          • Jane Hui, MD
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
          • Oncology Access Nurse
          • Phone Number: 612-624-2620
          • Email: ccinfo@umn.edu
        • Principal Investigator:
          • Jane Hui, MD
      • Minneapolis, Minnesota, United States, 55404
      • Saint Louis Park, Minnesota, United States, 55426
      • Saint Paul, Minnesota, United States, 55101
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Recruiting
        • Englewood Hospital and Medical Center
        • Contact:
        • Principal Investigator:
          • Jennifer Marti, MD
    • New York
      • New York, New York, United States, 10011
        • Recruiting
        • Mount Sinai Chelsea
        • Principal Investigator:
          • Tara Balija, MD
        • Contact:
          • Contact: Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CRSU@mssm.edu
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Principal Investigator:
          • Tara Balija, MD
        • Contact:
          • Contact: Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CRSU@mssm.edu
      • New York, New York, United States, 10019
        • Recruiting
        • Mount Sinai West
        • Principal Investigator:
          • Tara Balija, MD
        • Contact:
          • Contact: Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CRSU@mssm.edu
      • New York, New York, United States, 10003
        • Recruiting
        • Mount Sinai Union Square
        • Principal Investigator:
          • Tara Balija, MD
        • Contact:
          • Contact: Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CRSU@mssm.edu
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Institute
        • Contact:
        • Principal Investigator:
          • Ton Wang, MD
      • Winston-Salem, North Carolina, United States, 27157
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Active, not recruiting
        • Bryn Mawr Hospital
      • Paoli, Pennsylvania, United States, 19301
        • Active, not recruiting
        • Paoli Hospital
      • Wynnewood, Pennsylvania, United States, 19096
        • Active, not recruiting
        • Lankenau Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Principal Investigator:
          • Ingrid Meszoely, MD
        • Contact:
          • Oncology nursing
          • Phone Number: 1-800-811-8480
          • Email: cip@vumc.org
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute
        • Contact:
        • Principal Investigator:
          • Kirstyn Brownson, MD
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
        • Principal Investigator:
          • Kandace McGuire, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Elacestrant
Investigational drug. Both pre- and post- menopausal subjects. Elacestrant 400mg PO with food once daily up to 36 months.
Experimental: 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.
Drug: 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.
Experimental: 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.
Drug: 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.
Other Names:
  • T+Ai
Active Comparator: 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.
Drug: 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.

Drug: 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
Drug: Letrozole
For postmenopausal women: standard oral doses of AI of choice: letrozole 2.5 mg daily.
Drug: Anastrazole
For postmenopausal women: standard oral doses of AI of choice: anastrozole 1 mg daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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
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)
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
Correlation of low-risk categorization at 6 months with subsequent rate of Invasive Ductal Cell Carcinoma progression at 3 years
3 years
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
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
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
% with contralateral reduction in qualitative and automated BPE and % reduction in contralateral breast density
6 months
Change in artificial intelligence predicted risk based on mammography
Time Frame: 5 years
Correlation of BPE change with agent and compare to quantitative imaging density
5 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
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)
6 months
Determine adherence to active surveillance protocol
Time Frame: 5 years
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.
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess Germ Line polygenic risk: assess correlation of detectable mutations with endocrine response and qualification for active surveillance at 7 months
Time Frame: 7 months
evaluate influence of polygenic risk on endocrine response and suitability for Active Surveillance
7 months
To evaluate outcomes stratified by immune and molecular subtype based upon multiplex immuno histochemistry (IHC) clustering analysis, and RPS expression array profiling
Time Frame: 7 months
Response stratified by multiplex immune staining for Human Epidermal growth factor receptor-2 (HER2) isoforms and Response Predictive Subtypes (RPS)
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

QuantumLeap Healthcare Collaborative

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2024

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2033

Study Registration Dates

First Submitted

September 22, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECAST-DCIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe