A Phase II Preoperative Single-Fraction Partial Breast Radiotherapy in Early Stage Breast Cancer: Analysis of Pathologic Response
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis
研究概览
简要总结
This protocol seeks to build on the favorable results of the investigators' phase I trial (Pro00015617) by extending the findings to a larger cohort of subjects.In this study, the investigators hypothesize that 21Gy (Gray) as a single fraction can be delivered preoperatively to a larger group of subjects (n100).
The primary objective is to determine physician reported rates of good/excellent cosmesis at baseline and 6 months, 1, 2, and 3 years post-treatment as measured by the NRG cosmesis scale
详细描述
The study team hypothesizes that a single fraction of 21Gy can be delivered preoperatively to the intact breast tumor with acceptable cosmetic outcomes. Furthermore, the investigators anticipate that pre- and post-radiation breast tumor samples will provide an avenue for understanding breast cancer radiation response
Rationale for single-fraction preoperative technique
This trial is proposed to build on the favorable results of the investigators' phase I trial by extending the findings to a larger cohort of subjects. The preoperative approach has several advantages:
- a small intact breast tumor results in significantly less uninvolved breast tissue receiving high radiation doses which likely decreases toxicity;
- more accurate targeting of the high-risk areas of subclinical disease surrounding the tumor is possible,
- smaller treatment volumes are amenable to dose escalation which can further accelerate treatment and improve accessibility for subjects,
- this technical approach is widely utilized in other tumor sites and can be delivered at most radiation facilities
- the pre-operative approach provides a novel opportunity to study breast cancer radiation response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
- •a. Biopsy tissue (either slides or block) from outside institutions will be reviewed to confirm diagnosis.
- •Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery)
- •Clinical T1N0M0 invasive carcinoma or Ductal carcinoma in situ (DCIS) < or equal to 2cm
- •60 years of age or older or 50-59 with a low Oncotype score (0-17) Oncotype is not required for women diagnosed with DCIS.
- •Estrogen receptor positive (ER+), Human epidermal growth factor 2 negative (HER2-) HER-2 status is not required for women diagnosed with DCIS.
- •Women of child-bearing potential must consent to use adequate contraception during the course of the study. Female subjects must agree to use a medically acceptable contraceptives including: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). Contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use.
- •White blood cells (WBC) > 3000, Hemoglobin ( Hgb) > 9, platelets >100000 within 30 days of consent
- •Eligible for contrasted magnetic resonance imaging (MRI) on initial evaluation with glomerular filtration rate (GFR) ≥ 60 ml/min. A diagnostic MRI ordered within one month will be considered an acceptable alternative and will not be repeated.
- •Outside breast imaging will be reviewed at Duke to confirm findings are consistent with trial eligibility.
排除标准
- •Neoadjuvant chemotherapy
- •Breast implant in the breast to be treated with SBRT
- •Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma)
- •Subjects unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length
- •HER2 positive
- •Positive serum pregnancy test
- •Insufficient breast imaging to judge clinical stage
- •Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement.
- •Subjects in whom treatment planning constraints cannot be met
研究组 & 干预措施
Single arm 21Gy stereotactic radiotherapy
Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.
干预措施: Stereotactic body radiotherapy ( SBRT) (Radiation)
结局指标
主要结局
Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis
时间窗: 6 months
Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis
时间窗: 1 year
Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis
时间窗: 2 years
Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis.
时间窗: 3 years
Physician will independently complete the physician NRG Oncology cosmesis scale at the designated time points. The evaluation categories are Excellent; Good; Fair; Poor. The outcome measure is the rate of good or excellent cosmesis scores relative to all cosmesis evaluations. The higher the fraction is considered the better outcome.
次要结局
- Local Control in the Treated Breast Relative to Historic Controls(Through study completion estimated to be 10 years)
- Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis(baseline)
- Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis(6 months)
- Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis(12 months)
- Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis(2 year)
- Number of Participants With Patient Reported Rates of Good/Excellent Cosmesis(3 year)