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Brachytherapy

Accelerated Radiation Therapy 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

Must not have

History of DCIS or invasive breast cancer prior to the current diagnosis

Active collagen-vascular disease

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had breast cancer or DCIS before my current diagnosis.

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I have an active collagen-vascular disease.

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I have had radiation therapy on my chest or breast before.

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I have cancer in both breasts at the same time.

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My surgery did not remove all cancer cells or couldn't be checked.

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My surgery area cannot be clearly identified by my doctor.

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I have Paget's disease of the breast.

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My breast cancer is found in more than one location.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, one year, three years, and five years following irradiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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.

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