Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Response to neoadjuvant endocrine therapy (NET)
研究概览
简要总结
The goal of this clinical trial is to determine how the duration of hormone blocking (endocrine) therapy given prior to surgery (called "neoadjuvant" treatment) affects breast cancer. The main questions the trial aims is answer are:
- How breast cancer responds to endocrine therapy given prior to surgery?
- To predict tumor pre-operative endocrine prognostic index (PEPI) score for subjects enrolled in cohort B or C
Participants with early-stage breast cancer (Stage I-III) who are eligible for Neoadjuvant Endocrine Therapy (NET) will be enrolled in the study. Participants will:
- receive endocrine therapy as part of regular care for breast cancer
- consent to samples of blood and tissue evaluation to determine how endocrine therapy effects the tumor
- participate in this research anywhere from 2 weeks to 1 year, depending on duration of endocrine therapy and when surgery will be performed
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
- •Be capable of signing and providing written consent in accordance with institutional and federal guidelines
- •Histologically or cytologically confirmed diagnosis of invasive carcinoma of the breast
- •Clinical stage 1 to 3 breast cancer
- •Candidate for surgical resection
- •Estrogen receptor > 10% positive stained cells based on most recent tumor biopsy and documented by a local laboratory or medical record.
- •HER2 negative or HER2 low breast cancer based on the most recent tumor biopsy and documented by a local laboratory or medical record. HER2 negative tumor is defined per American Society of Clinical Oncology and the College of American Pathologists guidelines,
- •Patients with HER2 low tumors are eligible as long as patients are not candidates for any HER2 directed therapy.
- •Ability to take oral medication
- •Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff
- •Age ≥ 21 years
排除标准
- •Inability to comply taking NET
- •Inability to comply to study procedures
研究组 & 干预措施
Cohort A: Short Duration NET
Patients in this cohort can be treated with NET up to 8weeks (<= 8 weeks)
干预措施: Neoadjuvant endocrine therapy (Drug)
Cohort B: Intermediate Duration NET
Patients in this cohort can be treated with NET > 8weeks but <=24 weeks
干预措施: Neoadjuvant endocrine therapy (Drug)
Cohort C: Extended Duration NET
Patients in this cohort can be treated with NET >24 weeks but <= 52 weeks
干预措施: Neoadjuvant endocrine therapy (Drug)
结局指标
主要结局
Response to neoadjuvant endocrine therapy (NET)
时间窗: From enrollment to the end of treatment at <=52 weeks
Response to neoadjuvant endocrine therapy is defined as clear margins (defined as greater than 1mm) measured in the surgical pathology report. The proportion of women in each cohort with response will be estimated with exact 95% binomial confidence intervals. This is a categorical outcome (Success/Failure). Success is defined as clear margins \>1mm; Failure is defined as margins ≤1mm.
次要结局
- Physicians will predict Preoperative Endocrine Prognostic Index (PEPI) score after NET for subjects enrolled in cohort B or C(From enrollment to the end of treatment at <=52 weeks)
- Physicians will predict Ki67 after NET: Ki67 Labeling Index (percentage of Ki67-positive tumor cells).(From enrollment to the end of treatment at <=52 weeks)
研究者
Pavani Chalasani
Professor of Medicine; Director, Division of Hematology Oncology
George Washington University