ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy

Официальное название

Accelerated Super-Hypofractionated Breast Brachytherapy - ASHBY Trial

Обзор

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.

Подробное описание

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

Вмешательства

• Препарат Accelerated partial breast irradiation
  High Dose Rate treatment delivery

Первичные конечные точки

• Assess the toxicity (at 1 and 3 years) of a 1.5-day APBI treatment course [Срок оценки: 1 year, and 5 years following irradiation]

Вторичные конечные точки (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. [Срок оценки: 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. [Срок оценки: 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©. [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 5 weeks, 6 months, and yearly through 5 years following irradiation]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Virginia Commonwealth University — Richmond

Идентификаторы

NCT: NCT06185205 · MCC-22-19248 · HM20027787

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗