NCT06897488招募中2 期
EMERALD: Endocrine Therapy oMission With Radiation in ER+ Breast Cancer: Assessing Quality of Life and Disease Control: a Prospective Phase II Trial
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
This clinical research study is to learn about the effects of giving radiotherapy alone after lumpectomy to patients who have early-stage, low-risk breast cancers and who are 60 years of age or older.
详细描述
Primary Objective:
To determine the 3- year DMFS rate of radiotherapy as adjuvant monotherapy for early stage, low risk breast cancers in patients aged ≥ 60 years
Secondary Objectives:
- To determine the HRQoL of patients ≥ 60 years with early stage, low risk breast cancer receiving adjuvant monotherapy with radiotherapy
- To determine the 3-year and 5-year risk of ipsilateral breast tumor recurrence (IBTR) for early-stage breast cancers treated with lumpectomy and adjuvant radiotherapy without endocrine therapy
- To quantify the 3-year and 5-year rates of local-regional recurrence, contralateral breast cancer, breast cancer-specific survival and overall survival and the 5 year rate of DMFS
- To determine the 5-year utilization of salvage mastectomy and other salvage therapies
- To determine late (up to 11 year) oncologic outcome data for patients accessible via chart review or phone call
- To determine the toxicities experienced by patients ≥ 60 years with early stage, low risk breast cancer receiving adjuvant monotherapy with radiotherapy
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of pathologically-confirmed invasive breast cancer
- •Age ≥ 60 years
- •Treatment with breast conserving surgery
- •Pathologic T stage of T1 or T2 with total tumor size ≤ 3cm including any component of DCIS that may exist in conjunction with invasive disease
- •Ki-67 . 20% and/or Oncotype 0-10 (Ultra Low)
- •Final surgical margins negative, defined as no tumor on ink. Lobular carcinoma in situ involving the final surgical margin will be disregarded.
- •Tumor must be estrogen receptor positive, progesterone receptor positive and HER2Neu non-amplified as per current College of American Pathologists guidelines
- •Clinical nodal stage cN0
- •If pathologic nodal staging is obtained, then pN0 or pN0(i+)
- •Patients have had or have a scheduled discussion with a breast medical oncologist regarding adjuvant treatment options
- •Patients who have met criteria 4.1.1-4.1.9 who never initiate endocrine therapy OR who initiate adjuvant endocrine therapy but discontinue it within 6 months of initiation * In some clinical scenarios, patients may have a particularly small volume of tumor, making it not be feasible for all of these biomarkers to be evaluated. In this scenario, if the PI and/or Protocol Collaborators are able to document that a patient is being treated as if they have luminal A (biologically favorable) breast cancer then the patient is eligible for enrollment if all other eligibility criteria are met.
排除标准
- •Node positive disease (N1-3)
- •Metastatic disease (M1)
- •Grade 3 disease and lymphovascular space invasion in the tumor
- •Synchronous bilateral breast cancer
- •Receipt of neoadjuvant therapy
- •Diagnosis of a collagen vascular disease associated with an increased incidence of radiation toxicities such as scleroderma or systemic lupus erythematosis
- •Diagnosis of other cancer within the prior 5 years, excluding basal or squamous cell carcinoma of the skin that has been treated
- •Patient with psychiatric illness/social situations that would limit compliance with study requirements
- •Prior radiotherapy to the index breast or recurrent cancer of the breast
- •Known carrier of a mutation associated with predisposition to breast cancer development, including BRCA1 or BRCA2
研究组 & 干预措施
Endocrine Therapy
Experimental
干预措施: Adjuvant Radiotherapy (Radiation)
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events
次要结局
未报告次要终点
研究者
研究点 (1)
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