Pre-Operative Window of Adjuvant Endocrine Therapy to Inform Radiation Therapy Decisions In Older Women With Early-Stage Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Number of Participants Who Changed Their Preference for Adjuvant Radiation Treatment
研究概览
简要总结
This is a prospective multisite exploratory study for women ≥ 65 years of age with early stage estrogen receptor positive (ER+) breast cancer. These individuals will be treated with 3 months of pre-operative endocrine therapy (pre-ET) with assessment of tolerance to the endocrine therapy by patient reported outcome (PRO) measures (patient surveys).
详细描述
This single arm pilot study evaluates the use of pre-operative endocrine therapy in women with early stage ER+ breast cancer who are 65 years or older and are scheduled to have breast conservation surgery (BCS). The purpose of this study is to see if tolerance of pre-operative endocrine therapy helps inform decisions on whether or not to omit radiation. Participants will be treated with the novel approach of 3 months of pre-operative endocrine therapy, so that the participants and providers will have some indication of tolerance prior to making a decision about radiation omission. Tolerance of the endocrine therapy will be assessed by patient reported outcome (PRO) measures during neoadjuvant and adjuvant endocrine therapy treatment periods. Breast cancer participants and their surgical oncologists will be asked their preference regarding radiation therapy before starting endocrine therapy and again pre-operatively. They will make a determination regarding radiation therapy as per standard care. The hypothesis is that knowledge of tolerance of endocrine therapy will influence the decision by the patient and the surgical oncologist whether or not to elect radiation omission.
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
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pre-operative endocrine therapy
All participants enrolled to the study will receive 3 months of pre-operative endocrine therapy (e.g. tamoxifen or aromatase inhibitors (AIs) such as letrozole, anastrozole, or exemestane). The choice and dose of endocrine therapy will be at the discretion of the treating medical oncologist.
干预措施: tamoxifen, letrozole, anastrozole, or exemestane (Drug)
Pre-operative endocrine therapy
All participants enrolled to the study will receive 3 months of pre-operative endocrine therapy (e.g. tamoxifen or aromatase inhibitors (AIs) such as letrozole, anastrozole, or exemestane). The choice and dose of endocrine therapy will be at the discretion of the treating medical oncologist.
干预措施: Patient reported outcomes (Behavioral)
结局指标
主要结局
Number of Participants Who Changed Their Preference for Adjuvant Radiation Treatment
时间窗: up to 6 months
Change in participant response to question regarding preference for adjuvant radiation treatment
Change in Surgeon Preference for Adjuvant Radiation Treatment
时间窗: up to 6 months
Change in surgical oncologist response to question regarding preference for adjuvant radiation treatment
次要结局
- Health Related Quality of Life Surveys as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS(Through 24 months after start of adjuvant treatment period)
- General Symptom Burden as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS(Through 24 months after start of adjuvant treatment period)
- Illness Perception as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS(Through 24 months after start of adjuvant treatment period)
- Beliefs About Medicine as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS(Through 24 months after start of adjuvant treatment period)
- Perceived Sensitivity to Medicine as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS(Through 24 months after start of adjuvant treatment period)
- Breast Cancer Beliefs as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS(Through 24 months after start of adjuvant treatment period)
- Treatment Decision as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS.(up to 90 days after surgery, chemotherapy completion, or RT completion, whichever is later)
- Perceptions Related to Medical Choices as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS.(Through 24 months after start of adjuvant treatment period)
- Depression and Anxiety as Predictive Measure for Endocrine Therapy Adherence(Through 24 months after start of adjuvant treatment period)
研究者
Shayna Showalter, MD
Sponsor-Investigator
University of Virginia