ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy

Breast Cancer Clinical Trial

— ASHBY  

Official title:

Accelerated Super-Hypofractionated Breast Brachytherapy - ASHBY Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06185205
• Other study ID #: MCC-22-19248
• Secondary ID: HM20027787
• Status: Recruiting
• Phase: Phase 2
• Start date: December 12, 2023
• Est. completion date: January 31, 2033

Study information

• Verified date: January 2024
• Source: Virginia Commonwealth University
• Contact: Lindsey Gwaltney, RN
• Phone: 804-628-2112
• Email: lbgwaltney[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 31, 2033
• Est. primary completion date: January 31, 2031
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 79 Years

Eligibility

Inclusion 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Accelerated partial breast irradiation
High Dose Rate treatment delivery

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year, and 5 years following irradiation
Secondary	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.	Baseline, one year, three years, and five years following irradiation
Secondary	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.	Baseline, one year, three years, and five years following irradiation
Secondary	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.	Baseline, one year, three years, and five years following irradiation
Secondary	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	Baseline, one year, three years, and five years following irradiation
Secondary	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.	up to three and five years after irradiation
Secondary	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.	up to five years after irradiation