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DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-evaluering af betingelser for aktiv overvågnings egnethed som behandling

21. oktober 2026 opdateret af: QuantumLeap Healthcare Collaborative

DCIS: RECAST-forsøg - Duktalt karcinom in situ: Re-evaluering af betingelserne for aktiv overvågnings egnethed som behandling: en pilotundersøgelse til forebyggelse af brystkræft

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

400

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Kim Nelson, RN
  • Telefonnummer: 343 +1 (888) 343-9922
  • E-mail: k.nelson@qlhc.org

Undersøgelse Kontakt Backup

  • Navn: Tammy Neseth, MA, CCRP
  • Telefonnummer: +1 (507) 269-8060
  • E-mail: t.neseth@qlhc.org

Studiesteder

  • Forenede Stater
    • California
      • Berkeley, California, Forenede Stater, 94158
        • Rekruttering
        • Berkeley Outpatient Center
        • Kontakt:
        • Ledende efterforsker:
          • Jordan Jackson, MD
        • Kontakt:
      • Duarte, California, Forenede Stater, 91010
        • Rekruttering
        • City of Hope -Duarte Cancer Center
        • Ledende efterforsker:
          • Jennifer Tseng, MD
        • Kontakt:
          • Mellissa Henry, RN, MSN, FNP-C
          • Telefonnummer: 626-713-8895
          • E-mail: mehenry@coh.org
      • Irvine, California, Forenede Stater, 92618
        • Rekruttering
        • City of Hope - Lennar Foundation Cancer Center
        • Ledende efterforsker:
          • Jennifer Tseng, MD
        • Kontakt:
          • Mellissa Henry, RN, MSN, FNP-C
          • Telefonnummer: 626-713-8895
          • E-mail: mehenry@coh.org
      • Los Angeles, California, Forenede Stater, 90095
        • Rekruttering
        • UCLA
        • Kontakt:
        • Ledende efterforsker:
          • Mediget Teshome, MD
      • San Francisco, California, Forenede Stater, 94158
        • Rekruttering
        • UCSF
        • Ledende efterforsker:
          • Jordan Jackson, MD
        • Kontakt:
      • South Pasadena, California, Forenede Stater, 91030
        • Rekruttering
        • City of Hope
        • Ledende efterforsker:
          • Jennifer Tseng, MD
        • Kontakt:
          • Mellissa Henry, RN, MSN, FNP-C
          • Telefonnummer: 626-713-8895
          • E-mail: mehenry@coh.org
      • Walnut Creek, California, Forenede Stater, 94598
        • Rekruttering
        • John Muir Health
        • Kontakt:
        • Ledende efterforsker:
          • Monica Eigelberger, MD
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20010
        • Rekruttering
        • MedStar Washington Hospital Center
        • Ledende efterforsker:
          • Marc Boisvert, MD
        • Kontakt:
    • Florida
      • Tampa, Florida, Forenede Stater, 33612
        • Rekruttering
        • Moffitt Cancer Center
        • Kontakt:
        • Ledende efterforsker:
          • Laura Kruper, MD
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Rekruttering
        • Winship Cancer Institute, Emory University
        • Ledende efterforsker:
          • Clara Farley, MD
        • Kontakt:
        • Kontakt:
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
    • Minnesota
      • Maple Grove, Minnesota, Forenede Stater, 55369
        • Rekruttering
        • Maple Grove Cancer Center
        • Kontakt:
          • Oncology Access Nurse
          • Telefonnummer: 612-624-2620
          • E-mail: ccinfo@umn.edu
        • Ledende efterforsker:
          • Jane Hui, MD
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • Rekruttering
        • University of Minnesota
        • Kontakt:
          • Oncology Access Nurse
          • Telefonnummer: 612-624-2620
          • E-mail: ccinfo@umn.edu
        • Ledende efterforsker:
          • Jane Hui, MD
      • Minneapolis, Minnesota, Forenede Stater, 55404
      • Saint Louis Park, Minnesota, Forenede Stater, 55426
      • Saint Paul, Minnesota, Forenede Stater, 55101
    • New Jersey
      • Englewood, New Jersey, Forenede Stater, 07631
        • Rekruttering
        • Englewood Hospital and Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Jennifer Marti, MD
    • New York
      • New York, New York, Forenede Stater, 10011
        • Rekruttering
        • Mount Sinai Chelsea
        • Ledende efterforsker:
          • Tara Balija, MD
        • Kontakt:
          • Contact: Site Public Contact
          • Telefonnummer: 212-824-7309
          • E-mail: CRSU@mssm.edu
      • New York, New York, Forenede Stater, 10029
        • Rekruttering
        • Icahn School of Medicine at Mount Sinai
        • Ledende efterforsker:
          • Tara Balija, MD
        • Kontakt:
          • Contact: Site Public Contact
          • Telefonnummer: 212-824-7309
          • E-mail: CRSU@mssm.edu
      • New York, New York, Forenede Stater, 10019
        • Rekruttering
        • Mount Sinai West
        • Ledende efterforsker:
          • Tara Balija, MD
        • Kontakt:
          • Contact: Site Public Contact
          • Telefonnummer: 212-824-7309
          • E-mail: CRSU@mssm.edu
      • New York, New York, Forenede Stater, 10003
        • Rekruttering
        • Mount Sinai Union Square
        • Ledende efterforsker:
          • Tara Balija, MD
        • Kontakt:
          • Contact: Site Public Contact
          • Telefonnummer: 212-824-7309
          • E-mail: CRSU@mssm.edu
      • The Bronx, New York, Forenede Stater, 10461
        • Rekruttering
        • Montefiore Medical Center (Hutchinson Campus Tower 1)
        • Kontakt:
        • Ledende efterforsker:
          • Sheldon Feldman, MD
        • Kontakt:
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Rekruttering
        • Duke Cancer Institute
        • Kontakt:
        • Ledende efterforsker:
          • Ton Wang, MD
      • Winston-Salem, North Carolina, Forenede Stater, 27157
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, Forenede Stater, 19010
        • Aktiv, ikke rekrutterende
        • Bryn Mawr Hospital
      • Paoli, Pennsylvania, Forenede Stater, 19301
        • Aktiv, ikke rekrutterende
        • Paoli Hospital
      • Wynnewood, Pennsylvania, Forenede Stater, 19096
        • Aktiv, ikke rekrutterende
        • Lankenau Medical Center
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Rekruttering
        • Vanderbilt University Medical Center
        • Ledende efterforsker:
          • Ingrid Meszoely, MD
        • Kontakt:
          • Oncology nursing
          • Telefonnummer: 1-800-811-8480
          • E-mail: cip@vumc.org
        • Kontakt:
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Rekruttering
        • Huntsman Cancer Institute
        • Ledende efterforsker:
          • Kirstyn Brownson, MD
        • Kontakt:
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23298
        • Rekruttering
        • Virginia Commonwealth University
        • Kontakt:
        • Ledende efterforsker:
          • Kandace McGuire, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Medicin: 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.

Medicin: 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

Medicin: Letrozole

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

Medicin: Anastrazole

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

Andre navne:
  • T+Ai
Eksperimentel: 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.
Medicin: Elacestrant

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patients remaining on active surveillance at 7 months
Tidsramme: 7 months

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 3 years

Correlation of low-risk categorization at 6 months with subsequent rate of Invasive Ductal Cell Carcinoma progression 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
Tidsramme: 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
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)
Tidsramme: 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
Tidsramme: 6 months

% with contralateral reduction in qualitative and automated BPE and % reduction in contralateral breast density
6 months
Determine adherence to active surveillance protocol
Tidsramme: 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
Change in artificial intelligence predicted risk based on mammography
Tidsramme: 5 years

Correlation of BPE change with agent and compare to quantitative imaging density
5 years

Andre resultatmål

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

Response stratified by multiplex immune staining for Human Epidermal growth factor receptor-2 (HER2) isoforms and Response Predictive Subtypes (RPS)
7 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

QuantumLeap Healthcare Collaborative

Efterforskere

  • Ledende efterforsker: Laura Esserman, MD, MBA, University of California, San Fancisco - Department of Surgery
  • Ledende efterforsker: (Co-PI) Kelly Hewitt, MD, FACS, Huntsman Cancer Institute at the University of Utah

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. februar 2024

Primær færdiggørelse (Anslået)

1. november 2028

Studieafslutning (Anslået)

1. november 2033

Datoer for studieregistrering

Først indsendt

22. september 2023

Først indsendt, der opfyldte QC-kriterier

4. oktober 2023

Først opslået (Faktiske)

10. oktober 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RECAST-DCIS

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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