Personalized Second Chance Breast Conservation (PSCBC): A Two Center Prospective Phase II Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Rate of treatment related adverse events as graded by CTCAE version 5.0
研究概览
简要总结
The goal of the study is to investigate the feasibility of enabling a second chance for breast conservation in patients with in-breast recurrences after a previous lumpectomy and RT, investigators propose to test partial breast irradiation with the target volume encompassing the entire surgical bed with 1.0-1.5 cm margins.
An additional goal of the study is to investigate the feasibility of enabling a second chance for breast conservation in patients with inbreast recurrences after a previous lumpectomy and PBI, the investigators propose to test whole breast RT (WBRT) with the target as the whole breast volume.
详细描述
Patients will be treated with the fractionation of 30 Gy in 5 fractions over 1-2 weeks, which is the accelerated fractionation scheme of choice for Radiation Therapy (RT) naïve patients at New York Presbyterian using EBRT or with the fractionation of 4050 cGy in 15 fractions over 3 weeks, based on the previous treatment that they received.
The main aim of the study is to evaluate the rate of early grade 3 toxicities with this approach.
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
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Isolated ipsilateral unifocal breast lesions
- •Limited size (< 2-3 cm) without evidence of skin involvement
- •Histologically proven invasive breast carcinoma or carcinoma in situ
- •Negative histologic margins of resection
- •Patients with 0 to 3 positive axillary lymph nodes without extracapsular extension
- •No synchronous distant metastases
- •Age ≥ 18 years
- •≥ 12 months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence
- •Previous WBI or IORT, brachytherapy or external beam partial breast treatment
- •Technical feasibility
- •Every kind of systemic therapy is allowed
- •Informed consent for clinical and research purposes signed
排除标准
- •Regional recurrences (axillary, supraclavicular)
- •Positive histologic margins at resection
- •Metastatic disease
- •Poor cosmesis from previous surgery and RT
- •Extensive Intraductal Component
研究组 & 干预措施
Radiation Therapy - PBI
Patients will be treated with the fractionation of 30 Gy in 5 fractions over 1-2 weeks, which is the accelerated partial breast irradiation (PBI) fractionation scheme of choice for RT naïve patients at New York Presbyterian using External Beam Radiation Therapy (EBRT)
干预措施: 600cGY x 5 fractions APBI (Radiation)
Radiation Therapy - WBRT
Patients will be treated with the fractionation of 4050 cGy in 15 fractions over 3 weeks, which is the standard whole breast RT (WBRT) fractionation scheme of choice for RT naïve patients at New York Presbyterian using External Beam Radiation Therapy (EBRT)
干预措施: 270cGy x 15 fractions WBRT (Radiation)
结局指标
主要结局
Rate of treatment related adverse events as graded by CTCAE version 5.0
时间窗: up to 1 year from completion of radiation treatment
The primary endpoint of the study is to test the feasibility in terms of acute toxicity of a protocol of partial breast re-irradiation for breast cancer treatment in a previously irradiated whole breast, as defined by the rate of grade ≥ 3 treatment-related skin, fibrosis, and breast pain AEs, as graded by CTCAE version 5.0.
次要结局
- Disease free survival (DFS) will be measured(60 months)
- Number of participants with late toxicity will be measured as graded by CTCAE version 5.0(up to 60 months)
- Overall Survival (OS) will be measured.(60 months)
- Number of participants who received subsequent mastectomy in the treated breast(60 months)
- Change in number of participants with skin changes(baseline, approx. week 1- week 2 of radiation, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months.)
- Number of participants who demonstrate local control(60 months)
- Change in Quality of life as assessed by Breast Cancer treatment outcome scale (BCTOS)(baseline, approx. week 1- week 2 of radiation, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months.)
- Number of participants who received subsequent mastectomy in the treated breast(6 months)
- Number of participants who received subsequent mastectomy in the treated breast(12 months)
- Number of participants who received subsequent mastectomy in the treated breast(24 months)
- Number of participants who received subsequent mastectomy in the treated breast(36 months)
- Number of participants who received subsequent mastectomy in the treated breast(48 months)