Impact of 18F-fluoroestradiol (FES) Positron Emission Tomography (PET) on the Therapeutic Treatment of Metastatic Breast Cancer Patients, Initially ER Positive and HER2 Negative, in Relapse After First-line Therapy Combining Hormone Therapy
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 153
- 试验地点
- 10
- 主要终点
- To assess the impact of ESTROTEP PET/CT on metastatic breast cancer patients management, initially ER+ and HER2-, in relapse after first-line treatment combining hormone therapy.
研究概览
简要总结
This is a multi-center study in France to evaluate the impact of ESTROTEP PET/CT results on the therapeutic management of patients with metastatic breast cancer (MBC).
Each patient will be screened to determine whether the patient meets all the inclusion criteria and none of the exclusion criteria.
After inclusion, a standardized pre ESTROTEP PET/CT questionnaire will be completed by the investigators to evaluate the initial management plan. Patient will perform the ESTROTEP PET/CT examination at visit 2. A standardized post ESTROTEP PET/CT questionnaire will then be completed by the investigators.
Patients will be followed for 12 months to evaluate their clinical status and standard of care investigations.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged at least 18 years old at the time of enrolment
- •Oestrogen-receptor positive primary breast cancer in IHC (ER ≥10%)
- •HER2-negative primary breast cancer (0, 1+, 2+ FISH negative)
- •Metastatic stage with at least one lesion identifiable on the conventional work-up other than a liver lesion
- •Patient relapsing under first-line treatment combining a CDK4/6inhibitor and hormone therapy
- •Patient having undergone an FDG PET/CT during follow-up of first-line treatment for metastatic tumour revealing the relapse or undergoing a baseline FDG PET/CT seeking the relapse during 2nd line staging (according to the recommendations of the Guide to Correct Use (GBU) for medical imaging tests). A period of 2 to 28 days will be respected between the 2 PET/CT scans (FDG/FES).
- •ECOG 0, 1 or 2
- •Life expectancy of at least 12 months
- •Patient registered with a Social Security scheme
- •Patient having signed an informed consent form
- •Patient able to follow the study procedures and fill in the quality of life questionnaires
排除标准
- •Isolated hepatic metastases (taking into account the high physiological hepatic uptake of FES)
- •Patients as first-line treatment for metastatic cancer or aftersecond-line treatment for metastatic cancer
- •Person presenting a known allergy to one of the components of EstroTep
- •Patients having been treated with a CDK4/6 inhibitor in combination with an SERM or SERD as first-line metastatic therapy
- •atients suffering from severe or known chronic liver or renal failure
- •Patient following a low-sodium diet or having alcohol consumption levels incompatible with the administration of EstroTep, according to the investigator's opinion
- •Woman of childbearing age with no effective means of contraception according to the investigator's opinion
- •Severe intercurrent disease or comorbidity assessed at risk
- •Persons referred to in articles L. 1121-5 to L. 1121-8 and L11222 of the French Public Health Code
研究组 & 干预措施
Prospective population
干预措施: 18F Fluoroestradiol Radiopharmaceutical with PET/CT (Drug)
结局指标
主要结局
To assess the impact of ESTROTEP PET/CT on metastatic breast cancer patients management, initially ER+ and HER2-, in relapse after first-line treatment combining hormone therapy.
时间窗: Change from baseline therapeutic measure at 15 days after ESTROTEP PET/CT
The percentage of patients for whom a substantial therapeutic measure was implemented following an analysis of the FES PET examination. This assessment will be performed prospectively by means of a standardised questionnaire completed by the prescribing clinician, when the request for an FES PET/CT is made. The therapeutic modality initially planned and the modality actually used may be determined by a multidisciplinary consultation meeting depending on the centre. This questionnaire will completed again within a maximum period of 15 days following the FES PET/CT in order to specify the final therapeutic measure. Substantial measures will be considered to be any major modifications made in terms of: therapeutic modalities, diagnostic modalities and follow-up modalities.
次要结局
未报告次要终点