Estrogen Receptor-positive Breast Cancer, Fulvestrant
Conditions
Brief summary
This study is focused on the value of 18F-FES-PET in predicting the Fulvestrant efficacy in hormone receptor-positive breast cancer. The imaging agent involved in this study is 16α-\[18F\]-fluoro-17β-estradiol (18F-FES).
Detailed description
This study is an open, multi-center and prospective clinical study, It is the first time investigators are examining this imaging agent in Chinese patients with breast cancer. The Chinese FDA has approved 18F-FES as an investigational tracer in a selective few research studies. The Chinese FDA has not approved this tracer for any use outside of research. In this research study, the investigators are investigating the use of a PET tracer called 18F-FES in patients with breast cancer. The purpose is to take images that can measure the amount of a protein called Estrogen Receptor, or 'ER' in breast tumors. The expression level of ER is tightly correlated with the Fulvestrant efficacy in patients with breast cancer. The investigators will take the pictures of the participant's residual tumor lesions using a PET/CT scanner with 18F-FES used as the tracer before and after the first cycle of Fulvestrant treatment. The investigators are trying to clarify the relationship between the clinical Fulvestrant efficacy and the amount change of 18F-FES uptake by breast tumor around the first cycle of Fulvestrant treatment. This could help them to predict the efficacy of endocrine therapy by monitoring the dynamic levels of ER in advance, and potentially help guide treatment of breast tumors in the future. 18F-FES was initially developed to image the primary breast tumor. In previous studies of 18F-FES conducted in humans, there were no adverse events (there have been no problems). While this is not the first time 18F-FES has been used in humans, it is the first study in which the investigators study its predictive value in the treatment efficacy in breast cancer.
Interventions
DEVICE18F-FES-PET
18F-FES-PET/CT imaging before and after cycle 1 treatment with the first line Fulvestrant
Sponsors
First Affiliated Hospital Xi'an Jiaotong University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years or older (required for legal consent) * Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%, see Appendix A) * Pathologically diagnosed metastatic breast cancer * Fulvestrant used as the first-line treatment * Have primary breast tumor that is at least 2 cm in diameter as measured in any dimension on either mammogram, ultrasound, or breast MRI * Have the ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the change percentage of 18F-FES SUV | At end of cycle 1 of Fulvestrant treatment (each cycle is 28 days) | The change percentage of 18F-FES standard uptake value (SUV) before and after cycle 1 of Fulvestrant treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The correlation between the change percentage of 18F-FES SUV and the clinical efficacy | From the enrollment time to the time of disease progression or 2 years' followup which comes first | To find the correlation between the change percentage of 18F-FES SUV and the clinical efficacy, and further to determine the cutoff of 18F-FES SUV change percentage that could predict beneficial efficacy of Fulvestrant in breast cancer |
Other
| Measure | Time frame | Description |
|---|---|---|
| clinical efficacy: RECIST criteria | From the enrollment time to the time of disease progression or 2 years' followup which comes first | The therapeutic efficacy of Fulvestrant in breast cancer patients, record as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to RECIST criteria |
Countries
China
Contacts
Primary ContactJin Yang
Backup ContactJin Jin
Outcome results
None listed