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DCIS: studio RECAST sul carcinoma duttale in situ: rivalutazione delle condizioni per l'idoneità della sorveglianza attiva come trattamento

21 ottobre 2026 aggiornato da: QuantumLeap Healthcare Collaborative

DCIS: Studio RECAST - Carcinoma duttale in situ: rivalutazione delle condizioni per l'idoneità alla sorveglianza attiva come trattamento: uno studio pilota sulla prevenzione del cancro al seno

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

400

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Kim Nelson, RN
  • Numero di telefono: 343 +1 (888) 343-9922
  • Email: k.nelson@qlhc.org

Backup dei contatti dello studio

  • Nome: Tammy Neseth, MA, CCRP
  • Numero di telefono: +1 (507) 269-8060
  • Email: t.neseth@qlhc.org

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Droga: 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.

Droga: 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

Droga: Letrozole

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

Droga: Anastrazole

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

Altri nomi:
  • T+Ai
Sperimentale: 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.
Droga: Elacestrant

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patients remaining on active surveillance at 7 months
Lasso di tempo: 7 months

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 6 months

% with contralateral reduction in qualitative and automated BPE and % reduction in contralateral breast density
6 months
Determine adherence to active surveillance protocol
Lasso di tempo: 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
Lasso di tempo: 5 years

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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Assess Germ Line polygenic risk: assess correlation of detectable mutations with endocrine response and qualification for active surveillance at 7 months
Lasso di tempo: 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
Lasso di tempo: 7 months

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

QuantumLeap Healthcare Collaborative

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

17 febbraio 2024

Completamento primario (Stimato)

1 novembre 2028

Completamento dello studio (Stimato)

1 novembre 2033

Date di iscrizione allo studio

Primo inviato

22 settembre 2023

Primo inviato che soddisfa i criteri di controllo qualità

4 ottobre 2023

Primo Inserito (Effettivo)

10 ottobre 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RECAST-DCIS

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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