Evaluation of the Unconformity of the Hormonal Status of Metastatic Lesions During a First Relapse of Breast Cancer Initially Expressing Estrogen Receptors: a Pilot Study on the Interest of PET With FES (EstroTEPCompar)
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|ClinicalTrials.gov Identifier: NCT03873428|
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : October 28, 2019
Breast cancer is a major public health issue despite therapeutic advances, it is the first cause of death cancer of women in Europe.
Several treatments may be proposed depending on the general condition of the patient, the characteristics of the initial tumor and the stage of the disease. The different treatments in metastatic relapse of hormone receptor-positive breast cancer are systemic treatments, such as hormone therapy, chemotherapy, targeted therapies, and possible supportive care, but also in some cases local treatments such as surgery and radiotherapy.
Comparative analysis of primary mammary tumors and their metastases has demonstrated the essential role of tumor heterogeneity, both in time and space, in the progression of the disease and the occurrence of resistance to treatments. Taking into account this intratumoral heterogeneity represents a major axis of improvement in the management of patients with breast cancer.
The use of innovative radiotracers such as 16α- [18F] -fluoro-17β-estradiol (FES) may allow in the future to better evaluate this tumor heterogeneity in patients with metastatic breast cancer through non-metastatic characterization. invasive different lesions. It will be possible to propose to each patient a more personalized care with possibly the administration, in addition to the systemic treatment, of a local treatment adapted to the characteristics of some secondary lesions likely to respond less well to the systemic treatment.
In this pilot study, the investigators would like to estimate the number of patients and the number of metastatic sites affected by tumor heterogeneity of estrogen receptor expression, which could benefit from specific management.
This study will concern a population of patients with first metastatic recurrence of hormone receptor-positive breast cancer initially, with at least one metastasis, who are candidates for treatment with hormone therapy.
|Condition or disease||Intervention/treatment||Phase|
|FES TEP in Detection of Estrogen Receptors||Other: FES PET||Not Applicable|
The main objective of this pilot study is to determine the unconformity rates for estrogen receptor expression in different metastatic lesions in patients with first metastatic recurrence of breast cancer initially expressing estrogen receptors.
Secondary objectives are:
- To study the influence of the FES PET could have for possible modifications of therapeutic management in these patients.
- Determine the rate of patients with additional positive FES lesions but without positive FDG lesions.
- Evaluate the response to chemotherapy at 3 months after using FDG-PET in clinical routine.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Unconformity of the Hormonal Status of Metastatic Lesions During a First Relapse of Breast Cancer Initially Expressing Estrogen Receptors: a Pilot Study on the Interest of Positron Emission Tomography (PET) With 16α- [18F] -Fluoro-17β-estradiol (FES).|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2021|
1 ) inclusion; 2 ) FGD PET / FES PET; 3) Hormone therapy
Other: FES PET
- Estrogen Receptor Gene Expression [ Time Frame: at the inclusion ]number of FDG+ / FES- lesions compared to the number of FDG+ / FES+ lesions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873428
|Contact: Claire Tabouret-Viaud, MD||+ 33 3 80 73 75 firstname.lastname@example.org|
|Contact: Emilie REDERSTORFF, PhD||+33(0)3 80 73 75 00 ext 34 61||ERederstorff@cgfl.fr|