Phase II Trial of Single Fraction Radiation Therapy (SFRT) at Roswell Park Cancer Institute for Select Patients With Early Stage Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Patients With Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
This phase II trial studies how well radiation therapy works in treating post-menopausal women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for breast cancer.
详细描述
PRIMARY OBJECTIVE:
I. For select patients with early stage breast cancer undergoing wide local excision followed by single fraction radiation therapy (SFRT), we will evaluate rates of observer-rated toxicity, cosmetic outcomes and patient satisfaction, objective measures of toxicity and quality of life as well as delivery of intended dose.
SECONDARY OBJECTIVE:
I. Locoregional control reported at five years.
OUTLINE:
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
- •Core needle biopsy (e.g. Mammotome, core, stereotactic, ultrasound guided) showing invasive mammary cancer (with or without concomitant ductal carcinoma or lobular carcinoma in situ) or ductal carcinoma in situ; acceptable histologic types of invasive mammary cancer include ductal, tubular, mucinous, papillary, cribriform and "NOS" (not otherwise specified); invasive lobular cancer is excluded
- •Age >= 50 years and postmenopausal with no menses for at least one year prior to study enrollment
- •Age > 70 years with invasive breast cancer clinical size =< 3 cm OR Age 50 - 70 years with invasive breast cancer clinical size =< 1.5 cm OR Age >= 50 years and postmenopausal with any grade ductal carcinoma in situ (DCIS) clinical extent =< 1.5 cm (clinical tumor size will be determined by pre-operative breast imaging-mammography, ultrasound and/or magnetic resonance imaging; in cases of multiple measurements, the largest recorded single dimension will be used to determine eligibility)
- •Hormone receptor status
- •Estrogen or progesterone receptor positive or
- •Estrogen and progesterone receptor negative and clinical tumor size =< 1.0 cm
- •Human epidermal growth factor receptor 2 (HER2)/neu negative on the core biopsy analysis defined as 0 or 1+ by immunohistochemistry or not amplified by fluorescent in situ hybridization analysis
- •Tumor >= 0.5 cm from skin as defined by breast ultrasound
- •Unicentric tumor
- •Axillary lymph nodes negative by pre-operative physical examination in all cases and pathologic examination from surgery for invasive disease
- •Negative surgical margins, defined as no margin-labeling ink on tumor cells from margin evaluation
排除标准
- •Initial core biopsy showing invasive lobular cancer
- •Estrogen receptor and progesterone receptor negative tumor with clinical size > 1 cm
- •Any Her 2+ breast cancer (immunohistochemistry 3+; or amplified by fluorescence in situ hybridization [FISH])
- •Cancer in a patient with a known inherited susceptibility mutation in breast cancer (BRCA)1 or BRCA2
- •Multicentric breast cancer (two foci of known cancer in the breast separated by greater than 5 cm, or in separate quadrants
- •Clinically or pathologically positive axillary lymph nodes
- •Any prior breast cancer
- •Prior breast radiation therapy
研究组 & 干预措施
Treatment (radiation therapy)
Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
干预措施: Quality-of-Life Assessment (Other)
Treatment (radiation therapy)
Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
干预措施: Therapeutic Conventional Surgery (Procedure)
Treatment (radiation therapy)
Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
干预措施: Radiation Therapy (Radiation)
Treatment (radiation therapy)
Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
时间窗: Up to 2 years
Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0.
Quality-of-life Assessments
时间窗: Up to 2 years
Will be rated by patients using the POST-B, the Functional Assessment of Chronic Illness Therapy (FACIT), and the Skindex-16.
Cosmetic Differences in the Treated Breast
时间窗: Up to 2 years
Will measure differences in the cosmetic size, shape, or texture of the breast. Cosmesis will be graded according to the Baker Scale. Patient reported cosmesis will also be evaluated using the Ontario Clinical Oncology Breast Cancer Questionnaire.
次要结局
- Locoregional Control Rate(At 5 years)
- Overall Survival(Up to 5 years)
- Disease Specific Survival(Up to 5 years)