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

Overview

About this study

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.

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 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.

 

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

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Carlos Vargas, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Laura Vallow, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Carlos Vargas, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

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