Overview

Study to Determine the Utility of FES-PET in the Prediction of Response to Fulvestrant in Women With Estrogen Positive Metastatic Breast Cancer

Status:
Completed
Trial end date:
2018-07-01
Target enrollment:
0
Participant gender:
Female
Summary
Effects of fulvestrant on the ERs may be evaluable by molecular imaging using positron emission tomography with the ER-specific FES tracer. In this study we will determine the utility of FES-PET in the prediction of response to fulvestrant 500 mg in women with estrogen positive metastatic breast cancer
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Zhimin Shao
Treatments:
Estradiol
Estrogens
Fulvestrant
Criteria
Inclusion Criteria:

1. Patients with a history of histological proven ER-positive primary breast cancer and,
whenever available, histological proven ER-positive recurrence.

2. No previous fulvestrant treatment

3. ER-antagonists should be discontinued for 5 weeks prior to FES-PET. The use of
aromatase inhibitors is allowed.

4. Age > 18

5. ECOG 0-2

6. Life expectancy > 6 months

7. Informed consent obtained

8. Able to comply with the protocol

Exclusion Criteria:

1. Presence of life-threatening visceral metastases

2. Evidence of central nervous system metastases

3. > 3 lines of endocrine therapy for metastatic disease

4. Isolated liver metastasis (high FES uptake by normal liver)