[18F]FTT Positron Emission Tomography (PET) in Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
This clinical trial studies how well fluorine F 18 fluorthanatrace ([18F]FTT) positron emission tomography (PET) works in imaging patients with breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) who are receiving standard of care (SOC) poly (ADP-ribose) polymerase (PARP) inhibitors with or without immune checkpoint inhibitors (ICI) to be able to detect clinical response to PARP inhibitor ± ICI treatment. [18F]FTT is a radiotracer that targets and binds to PARP1 which can potentially be used for the imaging of PARP1 expression using PET. Once administered, [18F]FTT targets and binds to PARP1. Upon PET, PARP1-expressing tumor cells can be visualized. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case, [18F]FTT. Because some cancers take up [18F]FTT it can be seen with PET. PARP inhibitors work as a targeted therapy by blocking an enzyme involved in repairing cell damage. It may cause tumor cells to die. ICI may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Combining [18F]FTT with a PET scan may help detect tumor cells better in patients with metastatic breast cancer who are receiving standard of care PARP inhibitors with our without ICI treatment.
详细描述
OUTLINE: Patients are assigned to 1 of 2 arms.
Arm I: Patients receive [18F]FTT intravenously (IV) and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy and again at 12 weeks. At least 1-7 days later, patients undergo SOC FDG PET/computed tomography (CT) and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening and during follow up.
Arm II: Patients receive [18F]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening.
After initial [18F]FTT PET imaging, patients are followed-up to 6 months or until disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patients must have histologically confirmed invasive breast cancer with metastatic disease
- •Patients must be candidates for treatment with PARP inhibitor as a single agent or for PARP inhibitor in combination with an ICI per treating physician discretion
- •Patients must have evaluable disease or at least one measurable lesion that can be assessed at baseline by CT (or magnetic resonance imaging [MRI]) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- •Age >= 18 years
- •Karnofsky performance status (KPS) >= 50% or Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Archival tissue (formalin-fixed paraffin-embedded [FFPE]) from at least one metastatic site biopsy should be available prior to study enrollment; if archival tissue is not available, then a metastatic site biopsy will be required during the study screening period
- •Patient must be willing to proceed with an on-treatment biopsy of metastatic site if an on-treatment [18F]FTT PET will be performed (at 12 ± 4 weeks after starting PARP inhibitor ± ICI treatment)
- •For women of childbearing potential, a negative serum pregnancy test is required within 7 days prior to [18F]FTT PET imaging on day
- •For women who obtain on-treatment (12-week) [18F]FTT imaging, a negative serum pregnancy test will be required within 7 days prior to [18F]FTT PET imaging
- •Men and women of reproductive potential need to agree to employ two highly effective and acceptable forms of contraception throughout their participation in the study
- •Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
- •Ability to understand and the willingness to sign a written informed consent document. Informed consent must be provided prior to any study specific procedures
排除标准
- •Patients with prior myelodysplastic syndrome or acute myeloid leukemia due to rare risk associated with PARP inhibitor therapy
- •Pregnant or breastfeeding women
- •Patient with a known hypersensitivity to the proposed PARP inhibitor product
- •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
- •Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of PARP inhibitor therapy (per investigator's discretion)
研究组 & 干预措施
Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Patients receive [18F]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy and again at 12 weeks. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening and during follow up.
干预措施: Electronic Health Record Review (Other)
Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Patients receive [18F]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening.
干预措施: Fludeoxyglucose F-18 (Other)
Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Patients receive [18F]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy and again at 12 weeks. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening and during follow up.
干预措施: Best Practice (Other)
Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Patients receive [18F]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy and again at 12 weeks. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening and during follow up.
干预措施: Biopsy of Breast (Procedure)
Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Patients receive [18F]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy and again at 12 weeks. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening and during follow up.
干预措施: Computed Tomography (Procedure)
Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Patients receive [18F]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy and again at 12 weeks. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening and during follow up.
干预措施: Fluorine F 18 Fluorthanatrace (Radiation)
Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Patients receive [18F]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy and again at 12 weeks. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening and during follow up.
干预措施: Immune Checkpoint Inhibitor (Drug)
Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Patients receive [18F]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy and again at 12 weeks. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening and during follow up.
干预措施: Poly (ADP-Ribose) Polymerase Inhibitor (Drug)
Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Patients receive [18F]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy and again at 12 weeks. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening and during follow up.
干预措施: Positron Emission Tomography (Procedure)
Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Patients receive [18F]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening.
干预措施: Best Practice (Other)
Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Patients receive [18F]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening.
干预措施: Biopsy of Breast (Procedure)
Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Patients receive [18F]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening.
干预措施: Computed Tomography (Procedure)
Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Patients receive [18F]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening.
干预措施: Electronic Health Record Review (Other)
Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Patients receive [18F]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening.
干预措施: Fluorine F 18 Fluorthanatrace (Radiation)
Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Patients receive [18F]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening.
干预措施: Immune Checkpoint Inhibitor (Drug)
Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Patients receive [18F]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening.
干预措施: Poly (ADP-Ribose) Polymerase Inhibitor (Drug)
Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Patients receive [18F]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening.
干预措施: Positron Emission Tomography (Procedure)
Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Patients receive [18F]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy and again at 12 weeks. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening and during follow up.
干预措施: Fludeoxyglucose F-18 (Other)
结局指标
主要结局
Overall response rate (ORR)
时间窗: Baseline up to 6 months
Will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria on poly (ADP-ribose) polymerase (PARP) inhibitor ± immune checkpoint inhibitor (ICI) treatment. Will use a boxplot to illustrate the difference of standard uptake value (SUV)max and SUVmean between responders and non-responders.
次要结局
- ORR(Baseline up to 6 months)