Definitive Radiation Therapy for Inoperable Breast Cancer

Официальное название

Multi-institutional Prospective Pilot Study of Definitive Breast Radiation Therapy for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery

Обзор

The purpose of this study is to find out if adding radiation therapy to routine medications for breast cancer helps in reducing and preventing the cancer from getting worse. Patients with a locally advanced breast cancer who cannot, or do not want to, undergo surgery are eligible to participate. Participation in this study does not prevent you from undergoing surgery in the future.

Подробное описание

Patients who cannot undergo surgical resection for either breast cancer or local control of metastatic cancer have limited effective treatment options. Treatments typically employed in the adjuvant setting have been found in the definitive setting to be inferior to surgery followed by adjuvant therapy. This raises the necessity of evaluating the use of ablative doses of radiation to provide durable local control of the tumor in such patients. Indeed, there is growing evidence that RT is effective in the adjuvant setting. This is a study of concurrent ultra-hypofractionated whole breast whole breast radiation delivered via simultaneous integrated boost to the gross tumor for breast cancer patients not undergoing surgery.

Вмешательства

• Лучевая терапия Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor
  Radiation with 26Gy to the whole breast and 40Gy simultaneous integrated boost to gross disease in the breast, in five fractions
• Лучевая терапия Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and ipsilateral axillary lymph nodes
  Radiation with 26Gy to the whole breast and regional nodes with a 40Gy simultaneous integrated boost to gross disease in breast and ipsilateral axillary nodal areas, in five fractions

Первичные конечные точки

• Treatment Safety [Срок оценки: 12 months]

Вторичные конечные точки (7)

• Acute Toxicity [Срок оценки: 12 months]
• Late Toxicity [Срок оценки: 5 years]
• Treatment Tolerability by EORTC QLQ-C30 [Срок оценки: 2 years]
• Treatment Tolerability by EORTC QLQ-BR42 [Срок оценки: 2 years]
• Tumor Response Rate in the Gross Disease Volume (40Gy) [Срок оценки: 1 year]
• Progression Free Rate in the Microscopic Disease Volume (26Gy) [Срок оценки: 1 year]
• Clinical Response in patients with Palpable Disease [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Biopsy proven invasive carcinoma of the breast, either lobular, ductal and/or no special type
• T1-T4, N0-2, M0-1 invasive breast carcinoma by radiological or clinical criteria
• Cancer is deemed unresectable, or the patient is a poor surgical candidate as determined following evaluation by a surgeon, or patient declines surgery.
• Life expectancy > 6 months
• Negative pregnancy test at the time of start of treatment in any female of reproductive age

Критерии исключения

• Concurrent systemic therapy (except for endocrine therapy, HER2-targeted therapy, or immunotherapy which are permitted)
• Prior radiation to ipsilateral breast or regional nodes
• Inability to receive study treatment planning and treatment secondary to body habitus

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Stony Brook University Cancer Center — Stony Brook

Идентификаторы

NCT: NCT07122713 · SBU-BREAST-DEFINE · IRB2024-00364

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗