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DCIS: ensayo RECAST de carcinoma ductal in situ: reevaluación de las condiciones para la idoneidad de la vigilancia activa como tratamiento

21 de octubre de 2026 actualizado por: QuantumLeap Healthcare Collaborative

DCIS: ensayo RECAST - Carcinoma ductal in situ: reevaluación de las condiciones para la idoneidad de la vigilancia activa como tratamiento: un estudio piloto de prevención del cáncer de mama

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Estimado)

400

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Kim Nelson, RN
  • Número de teléfono: 343 +1 (888) 343-9922
  • Correo electrónico: k.nelson@qlhc.org

Copia de seguridad de contactos de estudio

  • Nombre: Tammy Neseth, MA, CCRP
  • Número de teléfono: +1 (507) 269-8060
  • Correo electrónico: t.neseth@qlhc.org

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Berkeley, California, Estados Unidos, 94158
        • Reclutamiento
        • Berkeley Outpatient Center
        • Contacto:
        • Investigador principal:
          • Jordan Jackson, MD
        • Contacto:
      • Duarte, California, Estados Unidos, 91010
        • Reclutamiento
        • City of Hope -Duarte Cancer Center
        • Investigador principal:
          • Jennifer Tseng, MD
        • Contacto:
          • Mellissa Henry, RN, MSN, FNP-C
          • Número de teléfono: 626-713-8895
          • Correo electrónico: mehenry@coh.org
      • Irvine, California, Estados Unidos, 92618
        • Reclutamiento
        • City of Hope - Lennar Foundation Cancer Center
        • Investigador principal:
          • Jennifer Tseng, MD
        • Contacto:
          • Mellissa Henry, RN, MSN, FNP-C
          • Número de teléfono: 626-713-8895
          • Correo electrónico: mehenry@coh.org
      • Los Angeles, California, Estados Unidos, 90095
        • Reclutamiento
        • UCLA
        • Contacto:
          • Sophia Quiroz, Clinical Research Coordinator
          • Número de teléfono: 310-794-0130
          • Correo electrónico: SQuiroz@mednet.ucla.edu
        • Investigador principal:
          • Mediget Teshome, MD
      • San Francisco, California, Estados Unidos, 94158
        • Reclutamiento
        • UCSF
        • Investigador principal:
          • Jordan Jackson, MD
        • Contacto:
      • South Pasadena, California, Estados Unidos, 91030
        • Reclutamiento
        • City of Hope
        • Investigador principal:
          • Jennifer Tseng, MD
        • Contacto:
          • Mellissa Henry, RN, MSN, FNP-C
          • Número de teléfono: 626-713-8895
          • Correo electrónico: mehenry@coh.org
      • Walnut Creek, California, Estados Unidos, 94598
        • Reclutamiento
        • John Muir Health
        • Contacto:
        • Investigador principal:
          • Monica Eigelberger, MD
    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20010
        • Reclutamiento
        • MedStar Washington Hospital Center
        • Investigador principal:
          • Marc Boisvert, MD
        • Contacto:
    • Florida
      • Tampa, Florida, Estados Unidos, 33612
        • Reclutamiento
        • Moffitt Cancer Center
        • Contacto:
          • Neveen Abdo, Clinical Research Coordinator
          • Número de teléfono: 727-748-9345
          • Correo electrónico: Neveen.abdo@moffitt.org
        • Investigador principal:
          • Laura Kruper, MD
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Reclutamiento
        • Winship Cancer Institute, Emory University
        • Investigador principal:
          • Clara Farley, MD
        • Contacto:
          • Winship Clinical Trials Office
          • Número de teléfono: 1-404-778-1868
          • Correo electrónico: winshipcto@emory.edu
        • Contacto:
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637
    • Minnesota
      • Maple Grove, Minnesota, Estados Unidos, 55369
        • Reclutamiento
        • Maple Grove Cancer Center
        • Contacto:
          • Oncology Access Nurse
          • Número de teléfono: 612-624-2620
          • Correo electrónico: ccinfo@umn.edu
        • Investigador principal:
          • Jane Hui, MD
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • Reclutamiento
        • University of Minnesota
        • Contacto:
          • Oncology Access Nurse
          • Número de teléfono: 612-624-2620
          • Correo electrónico: ccinfo@umn.edu
        • Investigador principal:
          • Jane Hui, MD
      • Minneapolis, Minnesota, Estados Unidos, 55404
        • Reclutamiento
        • Hennepin Healthcare -Minneapolis
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Satya Bommakanti, MD
      • Saint Louis Park, Minnesota, Estados Unidos, 55426
        • Reclutamiento
        • Health Partners - Frauenshuh Cancer Center
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Rachel Lerner, MD
      • Saint Paul, Minnesota, Estados Unidos, 55101
        • Reclutamiento
        • Health Partners - Regions Hospital
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Rachel Lerner, MD
    • New Jersey
      • Englewood, New Jersey, Estados Unidos, 07631
        • Reclutamiento
        • Englewood Hospital and Medical Center
        • Contacto:
        • Investigador principal:
          • Jennifer Marti, MD
    • New York
      • New York, New York, Estados Unidos, 10011
        • Reclutamiento
        • Mount Sinai Chelsea
        • Investigador principal:
          • Tara Balija, MD
        • Contacto:
          • Contact: Site Public Contact
          • Número de teléfono: 212-824-7309
          • Correo electrónico: CRSU@mssm.edu
      • New York, New York, Estados Unidos, 10029
        • Reclutamiento
        • Icahn School of Medicine at Mount Sinai
        • Investigador principal:
          • Tara Balija, MD
        • Contacto:
          • Contact: Site Public Contact
          • Número de teléfono: 212-824-7309
          • Correo electrónico: CRSU@mssm.edu
      • New York, New York, Estados Unidos, 10019
        • Reclutamiento
        • Mount Sinai West
        • Investigador principal:
          • Tara Balija, MD
        • Contacto:
          • Contact: Site Public Contact
          • Número de teléfono: 212-824-7309
          • Correo electrónico: CRSU@mssm.edu
      • New York, New York, Estados Unidos, 10003
        • Reclutamiento
        • Mount Sinai Union Square
        • Investigador principal:
          • Tara Balija, MD
        • Contacto:
          • Contact: Site Public Contact
          • Número de teléfono: 212-824-7309
          • Correo electrónico: CRSU@mssm.edu
      • The Bronx, New York, Estados Unidos, 10461
        • Reclutamiento
        • Montefiore Medical Center (Hutchinson Campus Tower 1)
        • Contacto:
        • Investigador principal:
          • Sheldon Feldman, MD
        • Contacto:
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27710
        • Reclutamiento
        • Duke Cancer Institute
        • Contacto:
          • Breast Cancer Study Team
          • Número de teléfono: 919-660-1278
          • Correo electrónico: breastcl@dm.duke.edu
        • Investigador principal:
          • Ton Wang, MD
      • Winston-Salem, North Carolina, Estados Unidos, 27157
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, Estados Unidos, 19010
        • Activo, no reclutando
        • Bryn Mawr Hospital
      • Paoli, Pennsylvania, Estados Unidos, 19301
        • Activo, no reclutando
        • Paoli Hospital
      • Wynnewood, Pennsylvania, Estados Unidos, 19096
        • Activo, no reclutando
        • Lankenau Medical Center
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37232
        • Reclutamiento
        • Vanderbilt University Medical Center
        • Investigador principal:
          • Ingrid Meszoely, MD
        • Contacto:
          • Oncology nursing
          • Número de teléfono: 1-800-811-8480
          • Correo electrónico: cip@vumc.org
        • Contacto:
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84112
        • Reclutamiento
        • Huntsman Cancer Institute
        • Investigador principal:
          • Kirstyn Brownson, MD
        • Contacto:
    • Virginia
      • Richmond, Virginia, Estados Unidos, 23298
        • Reclutamiento
        • Virginia Commonwealth University
        • Contacto:
          • Massey CTO Breast Team
          • Número de teléfono: 804-628-6430
          • Correo electrónico: masseyctbrst@vcu.edu
        • Investigador principal:
          • Kandace McGuire, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.
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.
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.

Otros nombres:
  • T+Ai
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.
Droga: 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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patients remaining on active surveillance at 7 months
Periodo de tiempo: 7 months

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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 6 months

% with contralateral reduction in qualitative and automated BPE and % reduction in contralateral breast density
6 months
Determine adherence to active surveillance protocol
Periodo de tiempo: 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
Periodo de tiempo: 5 years

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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Assess Germ Line polygenic risk: assess correlation of detectable mutations with endocrine response and qualification for active surveillance at 7 months
Periodo de tiempo: 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
Periodo de tiempo: 7 months

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

QuantumLeap Healthcare Collaborative

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

17 de febrero de 2024

Finalización primaria (Estimado)

1 de noviembre de 2028

Finalización del estudio (Estimado)

1 de noviembre de 2033

Fechas de registro del estudio

Enviado por primera vez

22 de septiembre de 2023

Primero enviado que cumplió con los criterios de control de calidad

4 de octubre de 2023

Publicado por primera vez (Actual)

10 de octubre de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • RECAST-DCIS

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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