[18F] Fluoroestradiol (FES) PET as a Predictive Measure for Endocrine Therapy in Patients With Newly Diagnosed Metastatic Breast Cancer
概览
- 阶段
- 2 期
- 干预措施
- F-18 16 Alpha-Fluoroestradiol
- 疾病 / 适应症
- HER2/Neu Negative
- 发起方
- National Cancer Institute (NCI)
- 入组人数
- 99
- 试验地点
- 49
- 主要终点
- Negative predictive value of 18F FES uptake for response (CB), defined as the proportion of patients with a negative FES test result who have progressive disease
- 状态
- 进行中（未招募）
- 最后更新
- 11天前
概览
简要总结
This phase II trial studies F-18 16 alpha-fluoroestradiol (FES) positron emission tomography (PET)/computed tomography (CT) in predicting response to endocrine therapy in patients with newly diagnosed breast cancer that has spread to other parts of the body. FES is a radioactive form of the hormone estrogen and may "light up" where cancer is in the body. Diagnostic procedures using FES, such as FES PET/CT, may help measure the FES and help doctors predict how well the cancer will respond to treatment.
详细描述
PRIMARY OBJECTIVES: I. To determine the negative predictive value (NPV) of \[18F\]fluoroestradiol (FES) uptake for response (clinical benefit) at 6 months in patients with estrogen-receptor positive (ER+) metastatic breast cancer treated with first-line endocrine therapy. SECONDARY OBJECTIVES: I. To determine the test-retest reproducibility of quantitative assessment of tumor FES uptake by standardized uptake values (SUVs). II. To evaluate the accuracy of FES-PET/CT for predicting response in patients treated with first line endocrine therapy for metastatic breast cancer. III. To evaluate the accuracy of FES-PET/CT for predicting progression-free survival (PFS) in patients treated with first line endocrine therapy for metastatic breast cancer. IV. To examine the role of FES-PET/CT in predicting progressive disease (PD) or clinical benefit (CB), in concert with semi-quantitative interpretation of ER, progesterone receptor (PgR), and marker of proliferation Ki-67 (Ki-67). V. To evaluate the relationships among FES uptake, as measured by maximum SUV (SUVmax) and semi-quantitative ER from immunohistochemistry (IHC). VI. To evaluate FES SUVmax \< 1.5 as the optimal cutpoint for predicting progression-free survival (PFS) to first line endocrine therapy for metastatic breast cancer. VII. To determine the percent of eligible patients for whom biopsy is not feasible, i.e., determine the clinical utility of indirect assay of ER expression by FES-PET/CT. VIII. To evaluate the heterogeneity of tumor FES uptake in individual patients defined as variability in lesion's FES uptake. OUTLINE: Between 0 to 30 days before start of endocrine therapy, patients receive F-18 16 alpha-fluoroestradiol intravenously (IV) over 2 minutes and undergo PET/CT. Patients may undergo a second FES-PET/CT study at least 24 hours after the first study and no later than 10 days after the initial study. After completion of study, patients are followed up for 6 months and then periodically for up to 2 years.
研究者
入排标准
入选标准
- •Capable and willing to provide informed consent
- •Women must not be pregnant or breast-feeding. All females of childbearing potential must have a blood test or urine study within 7 days prior to FES PET/CT scan and \[18F\]-fluorodeoxyglucose (FDG)-PET/CT scan to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy or
- •Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- •Women of childbearing potential and sexually active males must use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
- •Patient is a postmenopausal woman, man, or premenopausal woman for whom standard endocrine therapy alone (tamoxifen, aromatase inhibitor \[AI\], with or without ovarian suppression or fulvestrant) is planned after FES-PET/CT is completed
- •Medically stable as judged by patient's physician
- •Life expectancy must be estimated by patient's physician at \> 6 months
- •Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (restricted to ECOG performance status \[PS\] 0-2 if age \> 70 years)
- •Patient must NOT have a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FES
排除标准
- 未提供
研究组 & 干预措施
Diagnostic (FES PET/CT)
Between 0 to 30 days before start of endocrine therapy, patients receive F-18 16 alpha-fluoroestradiol IV over 2 minutes and undergo PET/CT. Patients may undergo a second FES-PET/CT study at least 24 hours after the first study and no later than 10 days after the initial study.
干预措施: F-18 16 Alpha-Fluoroestradiol
Diagnostic (FES PET/CT)
Between 0 to 30 days before start of endocrine therapy, patients receive F-18 16 alpha-fluoroestradiol IV over 2 minutes and undergo PET/CT. Patients may undergo a second FES-PET/CT study at least 24 hours after the first study and no later than 10 days after the initial study.
干预措施: Positron Emission Tomography
Diagnostic (FES PET/CT)
Between 0 to 30 days before start of endocrine therapy, patients receive F-18 16 alpha-fluoroestradiol IV over 2 minutes and undergo PET/CT. Patients may undergo a second FES-PET/CT study at least 24 hours after the first study and no later than 10 days after the initial study.
干预措施: Computed Tomography
Diagnostic (FES PET/CT)
Between 0 to 30 days before start of endocrine therapy, patients receive F-18 16 alpha-fluoroestradiol IV over 2 minutes and undergo PET/CT. Patients may undergo a second FES-PET/CT study at least 24 hours after the first study and no later than 10 days after the initial study.
干预措施: Laboratory Biomarker Analysis
结局指标
主要结局
Negative predictive value of 18F FES uptake for response (CB), defined as the proportion of patients with a negative FES test result who have progressive disease
时间窗: At 6 months
FES-PET results will be assessed as positive or negative by quantitative or qualitative criteria. FES SUVmax \< 1.5 will be defined as quantitatively negative test result while one or more sites of active disease will be qualitatively negative test result. The reference standard is patient's tumor response categorized by either CB or PD at 6 months. As part of the preliminary analysis, rates of FES uptake negative results overall and next by tumor response status will be calculated. FES-PET test positive results will be compared in the two tumor response groups using a chi-square test.
次要结局
- FES SUVmax < 1.5 as the optimal cutpoint for predicting PFS(Up to 1 year)
- Test-retest reproducibility of quantitative assessment of tumor FES uptake by SUVs(Up to 6 months)
- FES SUVmax(Up to 6 months)
- Predictive accuracy of FES PET/CT for PFS, defined as the time from entry onto study until tumor progression or death from any cause(Up to 1 year)
- FES uptake, as measured by SUVmax and semi-quantitative ER from IHC(Up to 6 months)
- Significance of FES PET measures in predicting PD or CB, in concert with semi-quantitative interpretation of ER, PgR, and Ki-67(Baseline)
- Percent of eligible patients for whom biopsy is not feasible, i.e., clinical utility of indirect assay of ER expression by FES PET(Up to 6 months)
- Heterogeneity of tumor FES uptake in individual patients defined as variability in lesion's FES uptake(Up to 6 months)