NCT03137693终止不适用
A Phase II Study of Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer: Introduction of a Novel Form of Accelerated Partial Breast Radiotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Rate of Pathologic Complete Response (pCR)
研究概览
简要总结
This study involves a course of radiation to the tumor that is delivered BEFORE surgery. The type of radiation is called stereotactic ablative body radiation therapy (SABR). The purpose of this study is to evaluate the effects, good and/or bad, of pre-operative SABR specifically focusing on its ability to reduce the chances that additional breast surgery will be needed, reducing the amount of breast/heart/lung tissue that is irradiated, and to study the tumor-tissue effects of SABR. The usual treatment for patients with early-stage breast cancer who have breast-conserving treatment (BCT) is to receive radiotherapy AFTER surgery, targeting either the whole breast or part of the breast.
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
- •Understand and voluntarily sign an informed consent document prior to conducting any study related assessments or procedures.
- •Histologically proven invasive adenocarcinoma of breast.
- •Must have marker clip indicating location of target tumor in breast.
- •Unifocal tumor less than or equal to 2 cm based on contrast-enhanced prone-breast MRI.
- •Must be clinically and radiographically node negative (N0) to participate on this protocol. Clinically suspicious regional nodes by imaging or physical exam require biopsy evaluation to exclude disease involvement.
- •Appropriate candidate for breast-conserving surgery based on multi-disciplinary assessment.
- •Females age ≥ 50 years.
- •Able to tolerate prone body positioning during radiation therapy.
- •No prior ipsilateral-breast or thoracic radiotherapy.
- •As defined on MRI, target lesion must be at least 10 mm distance from skin (defined as volume encompassing first 3 mm from breast surface).
- •Must be estrogen receptor (ER) positive.
- •Must be negative for Her-2 amplification. (Either 1+ on semi-quantitative evaluation of immunostain or negative by fluorescent in-situ hybridization).
- •No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery in the investigator's opinion.
- •No history of an invasive malignancy (other than this breast cancer, or non-metastatic basal or squamous skin cancers) in the last 5 years.
- •Must not have received nor be planned for neoadjuvant chemotherapy prior to SABR or surgery.
- •ECOG performance status less than
- •Females of childbearing potential must have a negative urine pregnancy test prior to simulation and within seven days of SABR start.
排除标准
- •Have invasive lobular carcinoma.
- •Have a Tumor > 2 cm as measured on prone contrast-enhanced breast MRI.
- •Have presence of histologically proven lymph node disease.
- •Are not a candidate for breast conserving surgery.
- •Have had prior ipsilateral-breast or thoracic radiotherapy.
- •History of scleroderma or lupus erythematosus with either cutaneous manifestation or requiring active treatment.
- •An MRI defined target tumor that is within 10 mm of skin (defined as volume encompassing first 3 mm from skin surface).
- •Have amplification of Her-2 (Either 3+ by semi-quantitative immunostain or positive by Fluorescent in-situ hybridization (FISH)).
- •Have implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery in the investigator's opinion.
- •History of an invasive malignancy (other than this breast cancer, or non-metastatic basal or squamous skin cancers) in the last 5 years.
- •Have received or plan to receive neoadjuvant chemotherapy either before radiotherapy or before surgery.
- •A known carrier of BRCA1 or BRCA2 gene mutation.
- •Pregnant or unwilling to undergo pregnancy screening.
结局指标
主要结局
Rate of Pathologic Complete Response (pCR)
时间窗: 6 weeks post SABR
Rate of pathologic complete response following pre-operative SABR for early-stage breast carcinoma. pCR: The absence of residual invasive disease in the breast and in the axillary lymph nodes at the completion of the neoadjuvant treatment.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
不适用
A Phase II Study of Pre-Op SRS Followed by Surgical Resection for Brain MetastasesBrain Metastases, AdultNCT05341739Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)20
招募中
1 期
A phase II study of preoperative stereotactic radiation therapy boost combined with short-course immunotherapy (pembrolizumab versus placebo, randomized, double-blind) and standard chemotherapy in patients with newly diagnosed HER2-negative non-metastatic breast cancer with lack of early metabolic response in 18-fluorodeoxyglucoseFDG-PET/CT after 1st chemoterapy cycleHER2 negative breast cancerMedDRA version: 23.0Level: PTClassification code: 10083232Term: HER2 negative breast cancer Class: 100000004864CTIS2023-504145-31-00arodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy78
已完成
1 期
SBRT Pre-operatively for Pancreatic CancerPancreatic NeoplasmsNCT02308722University of Oxford12
进行中（未招募）
3 期
Pre-operative SRS or Post-operative SRS in Treating Cancer Patients With Brain MetastasesMalignant NeoplasmMetastatic Malignant Neoplasm in the BrainNCT03741673M.D. Anderson Cancer Center180
撤回
不适用
Stereotactic Radiation Therapy Before Surgery for the Treatment of Resectable Brain MetastasesMalignant Neoplasm, BrainBrain TumorNCT04069910Jonsson Comprehensive Cancer Center