NCT07654257尚未招募2 期
Single FrAction Interstitial BreaSt BracHytherApy (SASHA)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 134
- 试验地点
- 1
研究概览
简要总结
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 single fraction over 1 day. This is a method of delivering radiation therapy directly into or close to a tumor.
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
- 40 Years 至 85 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 40-85 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 (HER2)-positive, the patient is planning to receive or has already received 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 (ER)+, progesterone receptor (PR)+/-, HER2-
- •Grade 1-2 breast cancer
- •Tumor ≤2 cm in size
- •Note: If patients meet all the following criteria, the decision to avoid sentinel lymph node biopsy can be at the discretion of the breast surgeon:
- •50-69 years of age
- •Grade 1-2 breast cancer
- •Clinically negative axilla by ultrasound and/or magnetic resonance imaging (MRI)
- •ER+, PR+, HER2-
- •Tumor ≤2 cm in size
- •Agrees to comply with aromatase inhibitor recommendation
- •Ability to begin brachytherapy within 12 weeks following lumpectomy, re- excision of margins, or completion of chemotherapy
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Pregnant or breastfeeding
- •Active collagen-vascular disease
- •Paget's disease of the breast
- •Any prior history of DCIS or invasive breast cancer prior to the current diagnosis
- •Any prior history of breast radiation therapy (RT) or thoracic 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
- •Treatment with neoadjuvant chemotherapy
- •Excision cavity that cannot be clearly delineated or is not amenable to implant per the treating investigator
- •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
Partial Breast Irradiation
Experimental
Brachytherapy delivered with multiple interstitial catheters, given in a single fraction over 1 day
干预措施: Partial Breast Irradiation (Drug)
研究者
研究点 (1)
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