Breast CancerPhase 2ASHBYNCT06185205
ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy
A Phase 2 study testing Accelerated partial breast irradiation in people with Breast Cancer, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 79 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Accelerated partial breast irradiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2023to 31 Jan 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Massey CTO Breast Team, 804-628-6430, masseyctbrst@vcu.edu
Bridget Quinn, MD, Ph.D
About this study
Official title: Accelerated Super-Hypofractionated Breast Brachytherapy - ASHBY Trial
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.
Read the detailed description
This phase 2, single-arm prospective study has been designed to determine the safety of delivering accelerated partial breast irradiation (APBI) with a multicatheter interstitial implant in a short course over 1.5 days
- Conditions
- Breast Cancer
- Being tested
- Accelerated partial breast irradiation
- Keywords
- Breast Cancer, Ductal Carcinoma in situ (DCIS), Irradiation
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated partial breast irradiationDrug
High Dose Rate treatment delivery
| Study group | Role | What they receive |
|---|---|---|
| Accelerated Partial Breast Irradiation (APBI) | Experimental | 7.5 gray (Gy) × 3 fractions via multicatheter brachytherapy Receives: Drug: Accelerated partial breast irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the toxicity (at 1 and 3 years) of a 1.5-day APBI treatment course
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.
Measured: 1 year, and 5 years following irradiation
Secondary outcomes (8)
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.
Cosmesis will be assessed utilizing the Breast Cancer Treatment Outcome Scale (BCTOS-12), a self-report instrument that evaluated the aesthetic outcome after breast conserving surgery (BCS). the Aesthetic Status, is composed of eight items referring to the breast. the new Aesthetic Status comprises eight items: (1) "breast shape", (2) "breast texture", (3) "nipple appearance", (4) "breast tenderness", (5) "scar tissue", (6) "breast swelling", (7) "fit of bra", and (8) "breast sensitivity".
Patients are instructed to rate each item of the BCTOS questionnaire on a four-point rating scale evaluating the differences between the treated and untreated breast (1 = no difference to 4 = large difference). The score for each subscale is calculated as the mean of its items, with the score ranging from 1.00 to 4.00. A higher score reflects a poorer status.
Measured: Baseline, one year, three years, and five years following irradiation
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.
Cosmesis will be assessed utilizing the Breast Cancer Treatment Outcome Scale (BCTOS-12), a self-report instrument that evaluated the functional outcome after breast conserving surgery (BCS). The questionnaire comprises 12 items and assesses various aspects of patients' subjective perception of the surgical result. The new Functional Status comprises four items: (1) "arm heaviness", (2) "shoulder discomfort", (3) "arm discomfort", (4) "arm swelling". Patients are instructed to rate each item of the BCTOS questionnaire on a four-point rating scale evaluating the differences between the treated and untreated breast
(1 = no difference to 4 = large difference). The score for each subscale is calculated as the mean of its items, with the score ranging from 1.00 to 4.00. A higher score reflects a poorer status.
Measured: Baseline, one year, three years, and five years following irradiation
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©.
The radiation-specific module of this patient-reported outcome measure evaluates patient satisfaction with the cosmetic effects of radiation by utilizing the BREAST-Q© (intellectual property of Drs Andrea Pusic, Anne Klassen and Stefan Cano. The BREAST-Q© is owned by Memorial Sloan Kettering Cancer Center and The University of British Columbia (Copyright ©2012, Memorial Sloan Kettering Cancer Center and The University of British Columbia). There is no overall or total BREAST-Q© score, only scores for each independent scale. All BREAST-Q© scales are transformed into scores that range from 0-100. The scores are computed by adding the response items together and then converting the raw sum scale score to a score from 0-100. For all BREAST-Q© scales, a higher score means greater satisfaction or better QOL.
Measured: Baseline, one year, three years, and five years following irradiation
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 Harvard Cosmesis Scale
This physician-rated form will be used by the treating surgeon or radiation oncologist to score cosmesis at baseline and annually for 5 years, where Excellent= treated breast looks essentially the same as the contralateral breast as it relates to radiation effects. This includes patients with grade 1 punctate scarring. Good= minimal but identifiable radiation effects of the treated breast. This includes patients with grade 2 punctate scarring.
Fair= significant radiation effects readily observable. Poor= severe sequelae of breast tissue secondary to radiation effect
Measured: Baseline, one year, three years, and five years following irradiation
Determine the 3- and 5-year actuarial local control rate of breast cancer when treated with a 1.5-day course of APBI.
The number of participants that achieve complete responses, partial response, or relapse. Disease control will be assessed by physical examination and mammography.
Measured: up to three and five years after irradiation
Assess cumulative treatment-related breast toxicities for up to 5 years after a 1.5-day course of APBI
The number of participants that have a reportable adverse event (AE) per protocol criteria.
Measured: up to five years after irradiation
Conduct detailed evaluation of the severity of punctate scarring at 5 weeks, 6 months, and yearly through 5 years after a 1.5-day course of APBI
Incidence and grade of punctate scarring. Punctate scarring, defined as scarring from catheter sites, is assigned according to the following grading criteria (Table 5):
- No toxicity: not clearly visible from 3 feet away
- Grade 1a: clearly visible from 3 feet away and no palpable scars
- Grade 1b: clearly visible from 3 feet away and palpable scars at <25% of catheter sites) OR clearly visible at 3-10 feet and no palpable scar tissue
- Grade 1c: clearly visible from ≥10 feet away and no palpable scars OR clearly visible at <10 feet and palpable scars at <25% of catheter sites)
- Grade 2: prominent (ie, visible at ≥10 feet away) and palpable scar tissue
Measured: 5 weeks, 6 months, and yearly through 5 years following irradiation
Assess rates of skin changes after a 1.5-day course of APBI in African American and non-African American patients.
Incidence of skin changes after APBI in African American and non-African American patients.
Measured: 5 weeks, 6 months, and yearly through 5 years following irradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start12 Dec 2023
- Primary completion31 Jan 2031 (estimated)
- Study completion31 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bridget Quinn, MD, Ph.D, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185205
- Sponsor's protocol ID
- MCC-22-19248
- Other IDs
- HM20027787
- Acronym
- ASHBY
- Status last verified
- Nov 2025
- First submitted
- 14 Dec 2023
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Super-Hypofractionated Breast Brachytherapy - ASHBY Trial
- ClinicalTrials.gov ID
- NCT06185205
- Acronym / sponsor ID
- ASHBY / MCC-22-19248
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Ductal Carcinoma in situ (DCIS), Irradiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 31 Jan 2031 (estimated)
- Study completion
- 31 Jan 2033 (estimated)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This phase 2, single-arm prospective study has been designed to determine the safety of delivering accelerated partial breast irradiation (APBI) with a multicatheter interstitial implant in a short course over 1.5 days
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accelerated Partial Breast Irradiation (APBI) | Experimental | Drug: Accelerated partial breast irradiation7.5 gray (Gy) × 3 fractions via multicatheter brachytherapy |
Who may qualify
- Ages
- 45 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated partial breast irradiationHigh Dose Rate treatment delivery | Drug | Accelerated Partial Breast Irradiation (APBI) |
Primary outcome
Assess the toxicity (at 1 and 3 years) of a 1.5-day APBI treatment course
Time frame: 1 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.
8 secondary outcomes
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.
Time frame: Baseline, one year, three years, and five years following irradiation
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.
Time frame: Baseline, one year, three years, and five years following irradiation
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©.
Time frame: Baseline, one year, three years, and five years following irradiation
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 Harvard Cosmesis Scale
Time frame: Baseline, one year, three years, and five years following irradiation
Determine the 3- and 5-year actuarial local control rate of breast cancer when treated with a 1.5-day course of APBI.
Time frame: up to three and five years after irradiation
Assess cumulative treatment-related breast toxicities for up to 5 years after a 1.5-day course of APBI
Time frame: up to five years after irradiation
Conduct detailed evaluation of the severity of punctate scarring at 5 weeks, 6 months, and yearly through 5 years after a 1.5-day course of APBI
Time frame: 5 weeks, 6 months, and yearly through 5 years following irradiation
Assess rates of skin changes after a 1.5-day course of APBI in African American and non-African American patients.
Time frame: 5 weeks, 6 months, and yearly through 5 years following irradiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bridget Quinn, MD, Ph.D principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Accelerated partial breast irradiation in people with Breast Cancer, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Massey IIT Research Operations (804-628-6430, masseyepd@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the toxicity (at 1 and 3 years) of a 1.5-day APBI treatment course (time frame: 1 year, and 5 years following irradiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.