NCT06185205招募中2 期
Accelerated Super-Hypofractionated Breast Brachytherapy - ASHBY Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Assess the toxicity (at 1 and 3 years) of a 1.5-day APBI treatment course
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 T
- •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-)
- •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
排除标准
- •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
研究组 & 干预措施
Accelerated Partial Breast Irradiation (APBI)
Experimental
7.5 gray (Gy) × 3 fractions via multicatheter brachytherapy
干预措施: Accelerated partial breast irradiation (Drug)
结局指标
主要结局
Assess the toxicity (at 1 and 3 years) of a 1.5-day APBI treatment course
时间窗: 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.
次要结局
- 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.(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©.(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(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.(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(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(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.(5 weeks, 6 months, and yearly through 5 years following irradiation)
研究者
研究点 (1)
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