3'-Deoxy-3'-18F Fluorothymidine PET/CT in Predicting Response To Chemotherapy Before Surgery in Patients With Locally Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 27
- 主要终点
- %Change in FLT Uptake Between the Baseline (Pre-therapy) and the Early-therapy Imaging Studies to Predict Pathological Complete Response
研究概览
简要总结
This phase II trial studies how well 3'-deoxy-3'-18F fluorothymidine (18F-FLT) positron emission tomography (PET)/computed tomography (CT) works in predicting response in patients receiving chemotherapy and undergoing surgery for breast cancer that has spread from where it started to nearby tissue or lymph nodes. Diagnostic procedures, such as 18F-FLT PET/CT, may help in learning how well chemotherapy works to kill breast cancer cells before surgery and help doctors plan the best treatment.
详细描述
PRIMARY OBJECTIVES:
I. To correlate the percentage change in standardized uptake value at 60 minutes (SUV60) between baseline (FLT-1) and early-therapy (FLT-2) with pathologic complete response to neoadjuvant chemotherapy of the primary tumor in patients with locally advanced breast cancer.
SECONDARY OBJECTIVES:
I. To demonstrate correlation between FLT-1 and post-therapy (FLT-3) uptake parameters and tumor proliferation markers in locally advanced breast cancer.
II. To evaluate the relationship between FLT-1, FLT-2 and FLT-3 uptake parameters and pathologic complete response of the primary tumor and residual cancer burden (RCB).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy
- •Locally advanced breast cancer, not stage IV, and with a tumor size >= 2 cm (as measured on imaging or estimated by physical exam)
- •No obvious contraindications for primary chemotherapy
- •Residual tumor planned to be removed surgically following completion of neoadjuvant therapy
- •Able to lie still for 1.5 hours for PET scanning
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- •Leukocytes >= 3,000/ul
- •Absolute neutrophil count >= 1,500/ul
- •Platelets >= 100,000/ul
- •Total bilirubin within normal institutional limits
- •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 times the institutional upper limit of normal
- •Creatinine within normal institutional limits OR creatinine clearance >= 30 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- •If female, postmenopausal for a minimum of one year, OR surgically sterile, OR not pregnant, confirmed by institutional standard of care (SOC) pregnancy test, and willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation
- •Able to understand and willing to sign a written informed consent document and a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
排除标准
- •Previous treatment (chemotherapy, radiation, or surgery) to involved breast; including hormone therapy
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Medically unstable
- •Condition requiring anesthesia for PET scanning and/or unable to lie still for 1.5 hours
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to F-18 fluorothymidine
- •Pregnant or nursing
- •Previous malignancy, other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, from which the patient has been disease free for less than 5 years
- •Currently on hormone therapy as the primary systemic neoadjuvant therapy
研究组 & 干预措施
Diagnostic (18F-FLT)
Patients undergo 18F-FLT PET /CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.
干预措施: CT (Procedure)
Diagnostic (18F-FLT)
Patients undergo 18F-FLT PET /CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.
干预措施: 18F-FLT (Drug)
Diagnostic (18F-FLT)
Patients undergo 18F-FLT PET /CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.
干预措施: PET (Procedure)
结局指标
主要结局
%Change in FLT Uptake Between the Baseline (Pre-therapy) and the Early-therapy Imaging Studies to Predict Pathological Complete Response
时间窗: Baseline (FLT-1) to early therapy (5-10 days after chemotherapy, FLT-2)
The primary statistical evaluation will be based on the percent change in FLT SUV60 between baseline (pre-therapy, FLT-1) and the early-therapy imaging (5-10 days after chemotherapy, FLT-2) studies
次要结局
- Correlation Between SUVmax and Ki-67 LI at FLT1(Baseline PET)(Baseline (FLT-1))
- Correlation Between SUVmax and Ki-67 LI at FLT3 (Post-NAC)(Post-NAC (FLT3))
- SUVmax at FLT-1 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III(Baseline (FLT-1))
- SUVmax at FLT-2 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III(early treatment (FLT2))
- SUVmax at FLT-3 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III(post-NAC (FLT-3))
- Change in Uptake Between FLT1 and FLT3 to Predict Pathologic Complete Response (pCR) of the Primary Tumor(Baseline (FLT-1) and post-NAC (FLT-3))
- %Change SUVmax From FLT1-FLT2 to Predict Lymph Node Status at Surgery(Baseline (FLT-1) and Early Therapy (FLT-2))
- %Change SUVmax From FLT1-FLT3 to Predict Lymph Node Status at Surgery(Baseline (FLT-1) and post-NAC (FLT-3))