ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy

Description

The purpose of this study is to compare any good and bad effects of giving radiation treatment for breast cancer in 3 treatments over about 2 days.

Conditions

Breast Cancer

Study Overview

Study Details

Study overview

The purpose of this study is to compare any good and bad effects of giving radiation treatment for breast cancer in 3 treatments over about 2 days.

Accelerated Super-Hypofractionated Breast Brachytherapy - ASHBY Trial

ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Richmond

Virginia Commonwealth University, Richmond, Virginia, United States, 23298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Female
  • * New diagnosis of ductal carcinoma in situ (DCIS) and/or invasive breast carcinoma per histologic evaluation
  • * Age 45-79 at diagnosis
  • * Previous lumpectomy with surgical margins histologically free of invasive tumor and DCIS as determined by the pathologist.
  • * T stage of Tis, T1, or T2.
  • * T2 tumors must be ≤3 cm in maximum diameter
  • * If the tumor is human epidermal growth factor receptor 2 (HER2)-positive, the patient must receive HER2-directed therapy.
  • * For patients with invasive breast cancer, an axillary staging procedure must be performed (either sentinel node biopsy alone or axillary dissection \[with a minimum of 6 axillary nodes removed\]) and the axillary node\[s\] must be pathologically negative.
  • * Note: N0(i+) is not an exclusion criterion.
  • * Note: Patients meeting all of the following criteria are not required to undergo the axillary staging procedure:
  • * ≥70 years of age
  • * estrogen receptor, Her2 = human epidermal growth factor receptor 2, PR = progesterone receptor negative (ER+PR+HER2-)
  • * G1-2
  • * Tumor ≤2 cm in size
  • * Agrees to comply with aromatase inhibitor recommendation
  • * Ability to understand and the willingness to sign a written informed consent document in English
  • * Pregnant or breastfeeding
  • * Active collagen-vascular disease
  • * Paget's disease of the breast
  • * History of DCIS or invasive breast cancer prior to the current diagnosis
  • * Prior breast or thoracic radiation therapy (RT) for any condition
  • * Multicentric carcinoma (DCIS or invasive)
  • * Synchronous bilateral invasive or non-invasive breast cancer
  • * Surgical margins that cannot be microscopically assessed or that are positive
  • * Excision cavity that cannot be clearly delineated per the treating investigator
  • * Any of the dosimetric treatment criteria defined in Section 6.1 have not been met. Patients who become ineligible due to inability to meet dosimetric criteria should not receive treatment as - defined in this protocol and will come off the study. Any subsequent adjuvant radiation will be delivered at the discretion of the treating physician
  • * Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements

Ages Eligible for Study

45 Years to 79 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Virginia Commonwealth University,

Bridget Quinn, MD, Ph.D, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

2033-01-31