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)