A Study to Evaluate Hypofractionated Radiotherapy to the Whole Breast or Post-mastectomy Chest Wall Including Regional Nodal Irradiation

Overview

About this study

The purpose of this study is to determine the safety of 5 fraction vs. 25 fraction radiation to the whole breast or post-mastectomy chest wall/reconstructed chest with regional nodal radiation.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 18 years.
  • Histological confirmation of breast cancer.
  • Breast conserving surgery or mastectomy (reconstruction is allowed).
  • Clinical or pathologic T1-T4c, N0-3, M0 disease.
  • ECOG Performance Status (PS) 0 to 2.
  • Able to and provides IRB approved study specific written informed consent.
  • Indications for breast or post mastectomy radiation with regional nodal radiotherapy per the discretion of the treating physician.
  • If uncertain of eligibility please consult the PI.

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 or PI, 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.
  • Prior receipt of ipsilateral breast or chest wall radiation.
  • Persistent positive margins on ink after definitive surgery either for DCIS or invasive cancer.
  • No active metastatic disease from other origin.
  • Recurrent breast cancer.
  • Patient requires bilateral breast radiation treatment.
  • cT4d patients (inflammatory breast cancer).
  • Patients that may not be compliant or fit for the study at the discretion of the PI.
  • Male patients.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Robert Mutter, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Laura Vallow, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Carlos Vargas, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions