RECRUITING

ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy

Conditions

Breast Cancer Ductal Carcinoma in situ (DCIS)Irradiation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Accelerated Super-Hypofractionated Breast Brachytherapy - ASHBY Trial

Quick Facts

Study Start:2023-12-12

Study Completion:2033-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06185205

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.

Ages Eligible for Study:45 Years to 79 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Massey IIT Research Operations

CONTACT

804-628-6430

masseyepd@vcu.edu

Principal Investigator

Bridget Quinn, MD, Ph.D

PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Study Locations (Sites)

Virginia Commonwealth University

Richmond, Virginia, 23298

United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-12

Study Completion Date2033-01-31

Study Record Updates

Study Start Date2023-12-12

Study Completion Date2033-01-31

Terms related to this study

Keywords Provided by Researchers

Breast Cancer
Ductal Carcinoma in situ (DCIS)
Irradiation

Additional Relevant MeSH Terms

Breast Cancer