ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy for Breast Cancer

This study, called ASHBY, is looking at a new way to give radiation treatment for breast cancer. It tests a treatment called Accelerated Partial Breast Irradiation (APBI) using High Dose Rate delivery, which involves giving three radiation treatments over about 1.5 to 2 days. The main goal is to see how safe this short treatment course is by checking for any side effects at 1 and 3 years after treatment. You may be able to join if you are a woman between 45 and 79 years old with a new diagnosis of ductal carcinoma in situ (DCIS) or invasive breast cancer, and have already had a lumpectomy where all cancer was removed. The study is currently unclear about its recruitment status and plans to enroll 170 participants.

Study design: This is a Phase 2 study that will involve 170 participants and does not compare the treatment to another group (single-arm).
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The study will assess side effects at 1 and 3 years after treatment, and measure the primary endpoint at 1 year and 5 years following irradiation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy

Recruiting

PHASE2Ages 45–79InterventionalTreatment

Virginia Commonwealth University

~170 participants

Updated 2025-11-21 on ClinicalTrials.gov

What's tested:Accelerated partial breast irradiation

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Assess the toxicity (at 1 and 3 years) of a 1.5-day APBI treatment course

Measured over 1 year, and 5 years following irradiation

Conditions

Breast Cancer

Where it's being run

1 sites across 1 states

Virginia1

Study leadership

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

Who to contact

Massey IIT Research Operations

[email protected]

804-628-6430

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

Assess the toxicity (at 1 and 3 years) of a 1.5-day APBI treatment course1 year, and 5 years following irradiation
Determine the incidence of accelerated partial breast irradiation (APBI) related toxicities, adverse events, of interest occurring at grade ≥3 within 1 year and 3 years after APBI. The APBI-related toxicities specified in Section 10.1 will be explicitly evaluated at all follow-up appointments. All APBI-related toxicities of interest will be captured, regardless of grade, beginning with the start of study treatment and continuing until the patient is off study utilizing study-specific grading criteria in place of Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

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