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Brachytherapy

Accelerated Partial Breast Irradiation (APBI) for Breast Cancer (ASHBY Trial)

Phase 2

Recruiting

Led By Bridget Quinn, MD, Ph.D

Research Sponsored by Virginia Commonwealth University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 45-79 at diagnosis

If the tumor is human epidermal growth factor receptor 2 (HER2)-positive, the patient must receive HER2-directed therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, one year, three years, and five years following irradiation

Awards & highlights

ASHBY Trial Summary

This trial aims to compare the benefits and risks of giving radiation treatment for breast cancer in three sessions over a span of approximately two days.

Who is the study for?

This trial is for individuals with breast cancer who are eligible for radiation therapy. Specific eligibility criteria are not provided, but typically participants would need to have a certain stage of cancer and be in good enough health to undergo the treatment.Check my eligibility

What is being tested?

The study is testing accelerated partial breast irradiation, which is a focused type of radiation therapy given over just three treatments in approximately two days, instead of the usual several weeks.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones from this type of radiation may include skin irritation at the treatment site, fatigue, breast pain or tenderness, and possible changes in breast size or shape.

ASHBY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was diagnosed with my condition between the ages of 45 and 79.

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If my cancer is HER2-positive, I must get HER2-targeted treatment.

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My breast cancer surgery included checking the underarm lymph nodes, which were cancer-free.

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My cancer is in an early stage and has not spread deeply.

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My T2 tumor is 3 cm or smaller.

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I have been newly diagnosed with a type of breast cancer.

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I am female.

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I had a lumpectomy and the edges of the removed tissue are cancer-free.

ASHBY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to three and five years after irradiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to three and five years after irradiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to three and five years after irradiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Assess cumulative treatment-related breast toxicities for up to 5 years after a 1.5-day course of APBI

Assess the rate of excellent or good cosmesis at baseline, 1, 3, and 5 years after a 1.5-day course of APBI utilizing the BREAST-Q©.

Assess the rate of excellent or good cosmesis at baseline, 1, 3, and 5 years after a 1.5-day course of APBI utilizing the Breast Cancer Treatment Outcome Scale.

+2 more

ASHBY Trial Design

1Treatment groups

Experimental Treatment

Group I: Accelerated Partial Breast Irradiation (APBI)Experimental Treatment1 Intervention

7.5 gray (Gy) × 3 fractions via multicatheter brachytherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Accelerated partial breast irradiation

2011

Completed Phase 4

~350

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor

699 Previous Clinical Trials

22,884,985 Total Patients Enrolled

18 Trials studying Breast Cancer

2,384 Patients Enrolled for Breast Cancer

Bridget Quinn, MD, Ph.DPrincipal InvestigatorVirginia Commonwealth University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for individuals to participate in this clinical trial?

"For potential participation in this clinical trial, patients must have a diagnosis of breast cancer and fall within the age range of 45 to 79. The study aims to enroll a total of 60 eligible individuals."

Answered by AI

What is the level of risk associated with utilizing Accelerated Partial Breast Irradiation (APBI) in treating patients?

"Based on our assessment, the safety of Accelerated Partial Breast Irradiation (APBI) is rated as 2. This rating reflects the available data indicating a certain degree of safety but lacking evidence regarding its effectiveness in this Phase 2 trial."

Answered by AI

Is there an age criterion that excludes individuals above 50 years from participating in this medical research study?

"To be considered eligible for participation in this trial, individuals must fall between the ages of 45 and 79. It is worth noting that there are a total of 71 clinical trials available for participants under 18 years old and an additional 2575 trials targeting individuals over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy

2023. "ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06185205.