A Pilot/Phase II Trial of Hypofractionated Radiotherapy to the Whole Breast Alone Before Breast Conserving Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Pathologic Complete Response (pCR) Rate Defined as a Residual Tumor Burden of 0-1 in the Surgical Specimen
研究概览
简要总结
This phase II trial studies how well hypofractionated radiation therapy works in treating participants with breast cancer before surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
详细描述
PRIMARY OBJECTIVES:
I. To determine the pathologic complete response (pCR) rate after hypofractionated radiotherapy to the whole breast alone, based on the postsurgical specimen.
SECONDARY OBJECTIVES:
I. To evaluate acute and late toxicity with preoperative radiation including grade >= 2 pneumonitis.
II. To estimate the 5-year locoregional control, distant recurrence, invasive disease-free survival, cause-specific survival, and overall survival.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation of breast cancer
- •Clinical stage T0-T2 N0 M0
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2
- •Able to and provides Institutional Review Board (IRB) approved study specific written informed consent
- •Study entry must be within 120 days of last biopsy (breast)
- •Able to complete all mandatory tests
- •Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
- •Planned breast surgery and indications for whole breast radiotherapy
排除标准
- •Medical contraindication to receipt of radiotherapy
- •Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or providing informed consent
- •Active systemic lupus or scleroderma
- •Pregnancy
- •Women of childbearing potential who are unwilling to employ adequate contraception
- •Prior receipt of ipsilateral breast or chest wall radiation
- •Recurrent breast cancer
- •Indications for comprehensive regional nodal irradiation
- •No neo-adjuvant therapy
研究组 & 干预措施
Treatment (hypofractionated radiation therapy)
Participants undergo hypofractionated radiation therapy daily for 5 days, then undergo standard of care surgery 4-16 weeks after radiation therapy.
干预措施: Hypofractionated Radiation Therapy (Radiation)
结局指标
主要结局
Pathologic Complete Response (pCR) Rate Defined as a Residual Tumor Burden of 0-1 in the Surgical Specimen
时间窗: up to 2 years
The proportion of successes (number of patients achieving pCR at time of definitive surgery) will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
次要结局
- Locoregional Control(Up to 5 years)
- Invasive Disease-free Survival(From registration until the time of disease recurrence or death due to any cause, assessed up to 5 years)
- Distant Recurrence(Up to 5 years)
- Overall Survival(From registration to death due to any cause assessed up to 5 years)
- Number of Participants With Acute Adverse Events (AE)(Up to 180 days post radiation therapy)
- Incidence of Late Adverse Events(Up to 5 years post radiation therapy)
- Cause-specific Survival(From registration to death due to breast cancer assessed up to 5 years)
- Disease- Free Survival(From registration until the time of disease recurrence or death due to any cause, assessed up to 5 years)