NCT05217966招募中不适用
Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS) for Low Risk Breast Cancer: A Phase II Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Incidence of pathological complete response
研究概览
简要总结
Eligible women will receive neoadjuvant single fraction radiotherapy followed by surgery performed after one year
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
- •Female aged 50 years or older.
- •Postmenopausal status (Defined as: age 60 OR bilateral ovariectomy OR amenorrhea > 12 months prior to breast cancer diagnosis without using oral contraceptives/hormone replacement therapy) (65).
- •World Health Organization (WHO) performance status 0-
- •Invasive ductal carcinoma proven by biopsy done ≤ 12 weeks from treatment start.
- •Unifocal disease on preoperative staging ultrasound or MRI done ≤ 12 weeks from treatment start.
- •Tumors less than or equal to 2cm clinically on physical exam, as well as on breast ultrasound.
- •No clinical evidence of nodal disease (i.e. cN0), on physical examination done ≤ 12 weeks from treatment start, as well as on breast ultrasound.
- •Estrogen receptor status (ER) positive on biopsy ≥ 80%.
- •Progesterone receptor status (PR) positive on biopsy ≥ 20%.
- •Her2 negative on biopsy.
- •No lymphovascular invasion on biopsy.
- •Low Oncotype DX recurrence score performed on biopsy specimen (RS ≤18).
- •Planned surgery is a partial mastectomy with sentinel lymph node biopsy.
排除标准
- •Age less than 50 years.
- •Premenopausal or uncertain menopausal status.
- •A known deleterious mutation in BRCA 1 and/or BRCA
- •Clinical tumor size > 2.0 cm in greatest diameter on staging ultrasound.
- •Tumor histology limited to lobular carcinoma only.
- •Clinically positive axillary nodes (cN+).
- •Lymphovascular invasion on biopsy.
- •Pure ductal or lobular carcinoma in situ on biopsy.
- •Extensive intraductal component on biopsy.
- •Neoadjuvant hormonal manipulation or chemotherapy.
- •Prior non basal cell or squamous cell skin cancers within 5 years.
- •More than one primary tumor in different quadrants of the same breast.
- •Diffuse microcalcifications on mammography.
- •Paget's disease of the nipple.
- •Previous irradiation to the ipsilateral breast.
- •Presence of an ipsilateral breast implant or pacemaker.
- •Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment.
- •Estrogen receptor status (ER) not known.
- •Currently pregnant or lactating.
- •Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol.
- •Geographic inaccessibility for follow-up.
- •Lack of preoperative staging with breast and axillary ultrasound.
- •Inability to adequately plan the patient for the experimental technique.
- •Prior breast cancer.
结局指标
主要结局
Incidence of pathological complete response
时间窗: 12 months
次要结局
- Incidence of grade 3 or greater radiation toxicity(0-5 years)
研究者
Michael Yassa
Radiation Oncologist
Maisonneuve-Rosemont Hospital
研究点 (4)
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