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A Study of Hypofractionated Radiotherapy to the Whole Breast Alone Before Breast Conserving Surgery

Overview

Información sobre este estudio

The purpose of this trial is to determine the patient's pathological response after hypofractionated radiotherapy to the whole breast based on a specimen after surgery. The analysis of tumor mutation may lead to a better understanding of the effect of radiotherapy in 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:

  • Age ≥ 18 years old.
  • Histological confirmation of breast cancer.
  • Clinical Stage T0-T2 N0 M0.
  • ECOG Performance Status (PS) 0 to 2.
  • Able to and provides IRB approved study specific written informed consent.
  • Study entry must be within 120 days of last biopsy (breast).         
  • Able to complete all mandatory tests listed in section 4.0.
  • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study).
  • Planned breast surgery and indications for whole breast radiotherapy.
  • No neo-adjuvant therapy.

Exclusion Criteria:

  • Medical contraindication to receipt of radiotherapy.
  • Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or providing informed consent.
  • Active systemic lupus or scleroderma.
  • Pregnancy.
  • Women of childbearing potential who are unwilling to employ adequate contraception.
  • Prior receipt of ipsilateral breast or chest wall radiation.
  • Recurrent breast cancer.
  • Indications for comprehensive regional nodal irradiation.

 

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

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Laura Vallow, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Carlos Vargas, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20447141

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