Single FrAction Interstitial BreaSt BracHytherApy

Официальное название

Single FrAction Interstitial BreaSt BracHytherApy (SASHA)

Обзор

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.

Вмешательства

• Препарат Partial Breast Irradiation
  16 Gy × 1 fraction via multicatheter brachytherapy delivered over 1 day

Первичные конечные точки

• Assess and compare the toxicity of a 1-day course of accelerated partial breast irradiation (APBI) to that of clinical trials: NSABP-B-39 (NCT00103181), RTOG-0413, TRIUMPH-T (NCT02526498), and ASHBY (NCT06185205) [Срок оценки: Baseline through 30 days following treatment, up to 5 years.]

Вторичные конечные точки (6)

• Assess the rate of excellent or good cosmesis at 1, 3, and 5 years after a 1-day course of APBI utilizing the Breast Cancer Treatment Outcome Scale (BCTOS-12) [Срок оценки: Baseline, 6 months, 1 year, 3 years, up to 5 years following treatment]
• Assess the rate of excellent or good cosmesis at 1, 3, and 5 years after a 1-day course of APBI utilizing the breast cancer core checklist (postoperative) (BREAST-Q) [Срок оценки: Baseline, 6 months, 1 year, 3 years, up to 5 years following treatment]
• Assess the rate of excellent or good cosmesis after a 1-day course of APBI utilizing the Harvard Cosmesis Scale [Срок оценки: Baseline, 6 months, then annually up to 5 years following treatment]
• Assess the rate of excellent or good cosmesis at 1, 3, and 5 years after a 1-day course of APBI assessed by Digital Photographs [Срок оценки: Baseline, 5 weeks, 6 months, annually up to 5 years following treatment]
• Assess cumulative treatment-related breast toxicities for up to 5 years after a 1-day course of accelerated partial breast irradiation (APBI) [Срок оценки: Baseline, up to 5 years following treatment]
• Determine the percentage of patients who remain free of local disease progression (e.g., tumor recurrence or local spread) of breast cancer when treated with a 1-day course of APBI [Срок оценки: 1 year, 3 years, and up to 5 years following treatment]

Критерии участия

Критерии включения

• Female
• 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

Критерии исключения

• 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

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: NCT07654257 · MCC-25-22764 · HM300001026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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