Impact of 18F-fluoroestradiol (FES) Positron Emission Tomography (PET) on the therapeutic treatment of patients with ER+ and HER2- metastatic breast cancer in relapse after first-line therapy combining hormone therapy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 9
- 主要终点
- 1. The therapeutic impact will be assessed by the percentage of patients for whom a substantial therapeutic measure has been implemented following the analysis of the PET-FES examination. This evaluation will be done using a standardized questionnaire filled in by the prescribing clinician prospectively, when requesting PET / CT at FES. This questionnaire will be completed again within a maximum of 15 days after the PET / CT FES in order to specify the final therapeutic measure.
研究概览
简要总结
To assess the impact of FES PET/CT on the management of patients with metastatic breast cancer initially presenting with overexpression of oestrogen receptors (ER) and absence of HER2 overexpression, in relapse after first-line treatment combining hormone therapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman aged at least 18 years old on inclusion
- •Primary breast cancer expressing hormonal estrogen receptors in IHC (ER ≥ 10%)
- •Primary breast tumor HER2 negative (0, 1+, 2+ FISH negative)
- •Metastatic stage with at least one lesion identifiable on the conventional work-up other than a hepatic lesion
- •Patient in a situation of recurrence of the first line of treatment combining a CDK4 / 6 inhibitor and a hormone therapy 6.Patient having performed a PET / CT with FDG during the follow-up of the first metastatic line defining the relapse or performing a PET / CT with the baseline FDG defining the relapse during the extension assessment of 2nd line (according to the recommendations of the GBU of the examinations of 'medical imaging). A period of 2 to 28 days will be respected between the 2 PET / CT (FDG / FES). 7.ECOG 0, 1 or 2
- •Life expectancy of at least 12 months
排除标准
- •Isolated hepatic metastases (taking into account the high physiological hepatic uptake of FES)
- •Patients in the first metastatic line or beyond the second metastatic line
- •Person with a known allergy to any of the components of EstroTep
- •Patients who have been treated with a CDK4 / 6 inhibitor in combination with a first-line metastatic SERM or SERD
- •Patient suffering from severe or known hepatic or renal failure
- •Patient under a low salt diet or having an alcohol intake incompatible with EstroTep administration according to the investigator judgment 7.Woman of childbearing potential without effective contraception according to the investigator judgement
- •Serious intercurrent illness or co-morbidity assessed as risk
结局指标
主要结局
1. The therapeutic impact will be assessed by the percentage of patients for whom a substantial therapeutic measure has been implemented following the analysis of the PET-FES examination. This evaluation will be done using a standardized questionnaire filled in by the prescribing clinician prospectively, when requesting PET / CT at FES. This questionnaire will be completed again within a maximum of 15 days after the PET / CT FES in order to specify the final therapeutic measure.
1. The therapeutic impact will be assessed by the percentage of patients for whom a substantial therapeutic measure has been implemented following the analysis of the PET-FES examination. This evaluation will be done using a standardized questionnaire filled in by the prescribing clinician prospectively, when requesting PET / CT at FES. This questionnaire will be completed again within a maximum of 15 days after the PET / CT FES in order to specify the final therapeutic measure.
1 cont. The treatment modality initially planned and that finally implemented can be determined in the RCP according to thecenters. For the same patient, the questionnaire will be completed by the same investigator. Any modification of:-therapeutic modalities•change in the type of hormone therapy molecule • addition of a hormone therapy molecule • withdrawal of a hormone therapy molecule • change in the type of chemotherapy molecule • addition of a chemotherapy molecule
1 cont. The treatment modality initially planned and that finally implemented can be determined in the RCP according to thecenters. For the same patient, the questionnaire will be completed by the same investigator. Any modification of:-therapeutic modalities•change in the type of hormone therapy molecule • addition of a hormone therapy molecule • withdrawal of a hormone therapy molecule • change in the type of chemotherapy molecule • addition of a chemotherapy molecule
1 cont.change in the type of other systemic treatment molecule•addition of other type of systemic treatment molecule•withdrawal of other type of systemic treatment molecule•addition of radiotherapy treatment•stopping radiotherapy treatment•change in radiotherapy technique•change in radiotherapy protocol•enlarged irradiation field of an already identified area•restricted irradiation field of an already identified area•programming of surgery•deprogramming of surgery
1 cont.change in the type of other systemic treatment molecule•addition of other type of systemic treatment molecule•withdrawal of other type of systemic treatment molecule•addition of radiotherapy treatment•stopping radiotherapy treatment•change in radiotherapy technique•change in radiotherapy protocol•enlarged irradiation field of an already identified area•restricted irradiation field of an already identified area•programming of surgery•deprogramming of surgery
- diagnostic modalities: • addition of a complementary exam • withdrawal of an additional examination • performing a biopsy - monitoring methods • adding an exam • withdrawal of an exam • increased frequency of follow-up • decrease in frequency of follow-up
- diagnostic modalities: • addition of a complementary exam • withdrawal of an additional examination • performing a biopsy - monitoring methods • adding an exam • withdrawal of an exam • increased frequency of follow-up • decrease in frequency of follow-up
次要结局
- 2nd line progression-free survival (PFS) is defined as the time between the date of the final therapeutic measure (treatment decision) and relapse, by comparing the medians of progression-free survival (PFS) in the study population and in the cohort historical. The comparison will be made by the Kaplan Meier test with a 12-month censorship.
- The relevance of the therapeutic measures put in place following the baseline PET / CT FES will be determined at 3 months on all the data in the patient's medical file (including the evaluation of the response to treatment) of the patient by an independent jury clinicians, made up of expert physician (oncologist, nuclear physician, radiotherapist, radiologist).
研究者
Jo Stevens
Scientific
GE Healthcare Limited