GENetic Risk Estimation of Breast Cancer Prior to Decisions on Preventive Therapy Uptake, Risk Reducing Surgery or Intensive Imaging Surveillance

Overview

Información sobre este estudio

The primary aim of this study is to determine if the addition of an individual polygenic risk score (PRS) in addition to the Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score will aid women at risk of breast cancer in making a decision to take (or not take) medications to prevent breast cancer.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Women > 35 years old and < 75 years old with at least one of the following:
    • A NCI-BCRAT 5 year risk of ≥ 3% which corresponds to the level in which there is moderate evidence of treatment benefit outweighing risk according to the US Preventative Services Task Force; or
    • IBIS (Tyrer-Cuzik) score for the 10 year risk of breast cancer of ≥ 8%;
    • History of atypical ductal hyperplasia or atypical lobular hyperplasia with a BCRAT ≥ 3% or IBIS ≥ 8%;
    • History of  lobular carcinoma in situ with a BCRAT ≥ 3% or IBIS ≥ 8%.

OR

  • Women ≥ 18 years old or ≤ 75 years old with a:
    • BRCA 1 or 2  mutation;
    • CHEK 2;
    • PALB 2;
    • ATM; or other hereditary breast mutation carrier per investigator; 

AND

  • Able to participate in all aspects of the study.
  • Understand and sign the study informed consent. 

Exclusion Criteria:

      1.  
  • Women whose BCRAT falls below the threshold (< 3% 5-year risk) of moderate benefit according to the US Preventative Task Force AND Women whose IBIS score is < 8% for the 10 year risk.
  • Women with known contra-indications to Tamoxifen, raloxifene ,exemestane, or anastrazole.
  • Current or prior use of Tamoxifen, raloxifene, exemestane or anastrazole for ≥ 6 months.
  • Unable to give informed consent.
  • Prior history of invasive breast cancer, ductal carcinoma in situ or other breast cancers.
  • Prior bilateral  prophylactic mastectomy.
  • Women who are currently pregnant.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Sandhya Pruthi, M.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Sabrina Sahni, M.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Barbara Pockaj, M.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available
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CLS-20468925

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