Genomically Guided Radiation Therapy in the Management of Triple Negative Breast Cancer

Официальное название

Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer

Обзор

The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) in people with triple negative (HER2 negative, hormone receptor negative) breast cancer undergoing breast conservation therapy.

Вмешательства

• Лучевая терапия Genomically Guided Radiation Therapy
  Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with or without a boost of 10 Gy in 5 fractions to the cavity.
• Лучевая терапия Genomically Guided Radiation Therapy
  Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with a boost of 10 Gy in 5 fractions to the cavity.

Первичные конечные точки

• Local Control [Срок оценки: At 3 Years]

Вторичные конечные точки (4)

• Overall Survival (OS) [Срок оценки: Up to 5 Years]
• Progression Free Survival (PFS) [Срок оценки: Up to 5 years]
• Distant Control [Срок оценки: Up to 5 Years]
• Quality of Life following Genomically Guided Dose Personalization [Срок оценки: Up to 5 Years]

Критерии участия

Критерии включения

• Participants should have undergone breast conservation therapy with a lumpectomy and axillary evaluation to consist of a sentinel node biopsy or axillary dissection
• Confirmation of Triple Negative (TN) breast cancer by tissue biopsy
• Adequate tissue to calculate RSI
• To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization as defined by the ASCO / CAP Guidelines
• To fulfill the requirement of hormone receptor (HR)- disease, a breast cancer must express (<10%), by immunohistochemistry (IHC), the hormone receptors (estrogen receptor \[ER\] and progesterone receptor \[PR\]) as defined in the American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) Guidelines
• Life expectancy >16 weeks
• KPS ≥ 70
• Age ≥ 18 years
• Participants with surgery within 14 days should have recovered from all effects of the surgery and be cleared by their surgeon
• There is no limit on prior systemic therapies
• Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study
• Ability to sign an informed consent form, which can be signed by a family member or health care proxy. Informed consent must be given before study enrollment

Критерии исключения

• Major surgery or significant traumatic injury that has not been recovered from 14 days before study initiation
• Women who are pregnant or breastfeeding
• Positive surgical margins
• History of allergy or hypersensitivity to any of the study drugs or study drug components
• Metastatic breast cancer

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 · 2 центра

• Morton Plant Hospital - Baycare Health System — Clearwater
• Moffitt Cancer Center — Tampa

Идентификаторы

NCT: NCT05528133 · MCC-21757

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗