Actively Recruiting

Phase 2
Age: 45Years - 79Years
FEMALE
NCT06185205

ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy

Led by Virginia Commonwealth University · Updated on 2025-11-21

170

Participants Needed

1

Research Sites

476 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy

Who Can Participate

Age: 45Years - 79Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female
  • New diagnosis of ductal carcinoma in situ (DCIS) and/or invasive breast carcinoma confirmed by histology
  • Age between 45 and 79 years at diagnosis
  • Previous lumpectomy with surgical margins free of invasive tumor and DCIS as confirmed by pathology
  • Tumor stage Tis, T1, or T2
  • T2 tumors must be 3 cm or smaller in maximum diameter
  • HER2-positive patients must receive HER2-directed therapy
  • For invasive breast cancer, axillary staging must be done with negative nodes (N0), except for certain patients aged 70 or older meeting specific hormone receptor and tumor size criteria
  • Ability to understand and willing to sign informed consent in English
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Active collagen-vascular disease
  • Paget's disease of the breast
  • History of DCIS or invasive breast cancer before the current diagnosis
  • Prior radiation therapy to the breast or chest area for any condition
  • Multicentric carcinoma (multiple tumor sites) in the breast
  • Synchronous bilateral invasive or non-invasive breast cancer
  • Surgical margins that are positive or cannot be microscopically assessed
  • Excision cavity that cannot be clearly defined by the investigator
  • Failure to meet required dosimetric treatment criteria
  • Medical, psychological, or social conditions that may increase risk or limit adherence to study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Actively Recruiting

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Research Team

M

Massey IIT Research Operations

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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