Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 4
- 主要终点
- Local Control
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
研究组 & 干预措施
Radiosensitivity Index not optimized
Participants will receive standard of care whole breast radiation therapy with or without regional lymph node irradiation as appropriate with a boost to the lumpectomy cavity.
干预措施: Genomically Guided Radiation Therapy (Radiation)
Radiosensitivity Index optimized
Participants will be assigned to optimized arm based on their RSI score. Participants will receive whole breast radiation therapy with or without regional lymph node irradiation as appropriate with or without a boost to the lumpectomy cavity.
干预措施: Genomically Guided Radiation Therapy (Radiation)
结局指标
主要结局
Local Control
时间窗: At 3 Years
Local control will be defined as lack of progression in the ipsilateral breast as documented by response assessment imaging
次要结局
- Overall Survival (OS)(Up to 5 Years)
- Progression Free Survival (PFS)(Up to 5 years)
- Distant Control(Up to 5 Years)
- Quality of Life following Genomically Guided Dose Personalization(Up to 5 Years)