NCT04360330招募中不适用
Phase I Study to Evaluate the Safety and Feasibility of Preoperative Ablative Breast Radiotherapy (SABER) for Selected Early Stage Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Recommended Phase 2 Dose (RP2D) of Pre-Operative SABER
研究概览
简要总结
The purpose of this study is to find the most effective dose of radiation therapy to give to breast tumors in a shorter period of time, prior to standard partial mastectomy/axillary surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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, ≥ 50 years of age.
- •Oncotype or MammaPrint diagnosis results are required prior to the start of treatment
- •Histologically confirmed invasive breast cancer.
- •Clinical stage T1N0M
- •Receptor status: Estrogen-Receptor (ER)/Progesterone-Receptor (PR) positive and Human Epidermal Growth Factor Receptor 2 (HER2) negative.
- •Unifocal breast cancer.
- •Eastern Cooperative Oncology Group (ECOG) 0,
- •Ability to undergo MRI.
- •Women of child-bearing potential (WOCBP) must agree to use adequate contraception or agree to undergo sexual abstinence prior to study entry and for the duration of study participation. WOCBP must have a negative serum or urine pregnancy test at time of enrollment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
- •Ability to understand the investigational nature, potential risks and benefits of the research study and willingness to sign the written informed consent and HIPAA document(s).
排除标准
- •Patients without histologically confirmed invasive breast cancer.
- •Patients without Oncotype or MammaPrint diagnosis results at the start of treatment.
- •Patients with metastatic disease.
- •Patients that are unable to undergo MRI.
- •Prior history of radiation to the chest.
- •History of collagenous disease (systemic lupus erythematosus, scleroderma, dermatomyositis).
- •Any serious medical or psychiatric illness/condition likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements/treatment.
- •Diagnosis of another primary malignancy within the last 5 years with the exception of non-melanoma skin cancer.
- •Patients unable to consent, who are pregnant or nursing, or are prisoners.
研究组 & 干预措施
Preoperative SABER
Experimental
- Experimental: Preoperative Stereotactic Ablative Breast Radiotherapy (SABER). Phase I study testing up to 4 dose levels.
- Non-experimental: Participants will undergo standard partial mastectomy and axillary surgery as per discretion of treating physician 4 to 6 weeks (+ at most 1 week delay) after preoperative SABER is completed.
干预措施: Stereotactic Ablative Breast Radiotherapy (Radiation)
结局指标
主要结局
Recommended Phase 2 Dose (RP2D) of Pre-Operative SABER
时间窗: Up to 13 Weeks
The recommended phase 2 dose (RP2D) of pre-operative SABER therapy will be established as the highest dose level tested for which no more than 1 out of 6 patients experience dose-limiting toxicity (DLT). Adverse Events (AEs) including DLTs will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
次要结局
- Number of Participants Experiencing Treatment-Related Toxicity(Up to 13 weeks)
- Percentage of participants with Complete Pathological Response (pCR)(Up to 9 weeks)
- Participant-Reported Health-Related Quality of Life (HR-QoL)(1, 6 ,12 and 24 months post-therapy, up to 2.5 years)
- Cosmesis Evaluation(1, 6 ,12 and 24 months post-therapy, up to 2.5 years)
研究者
Cristiane Takita
Professor of Clinical
University of Miami
研究点 (1)
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