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

NCT03507088 | Completed

• 1 other identifier: 1503144-6
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Metastatic Breast Cancer

Keywords

fulvestrant 500 mg; fluorine-18 fluoroestradiol PET-CT

Outcome Measures

Primary Outcomes (1)

• To evaluate the accuracy of the change of FES uptake in predicting progression-free survival(PFS) in patients treated with fulvestrant 500 mg

  The FES-uptake will be calculated for all tumor lesions in individual patient at baseline and 28 days. Therapy response will be monitored by regular follow-up. RECIST criteria and clinical benefit will be used as criteria. All patients will be followed up until disease progression.

  baseline; 28 days

Secondary Outcomes (1)

• Evaluate the heterogeneity of ER among different metastatic sites in breast cancer patients in vivo

  baseline

Study Arms (1)

fulvestrant

EXPERIMENTAL

500mg fulvestrant on days 0, 14, 28 and every 28 days thereafter Fluoroestradiol-PET is performed at baseline and after 28 days

Drug: Fluoroestradiol (18F)

Interventions

Fluoroestradiol (18F) DRUG

A FES-PET/(CT) will be performed twice during protocol execution. Patients will be injected with approximately 222 MBq 18F-FES each time.

fulvestrant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a history of histological proven ER-positive primary breast cancer and, whenever available, histological proven ER-positive recurrence.
• No previous fulvestrant treatment
• ER-antagonists should be discontinued for 5 weeks prior to FES-PET. The use of aromatase inhibitors is allowed.
• Age \> 18
• ECOG 0-2
• Life expectancy \> 6 months
• Informed consent obtained
• Able to comply with the protocol

You may not qualify if:

• Presence of life-threatening visceral metastases
• Evidence of central nervous system metastases
• \> 3 lines of endocrine therapy for metastatic disease
• Isolated liver metastasis (high FES uptake by normal liver)

Sponsors & Collaborators

• Zhimin Shao: lead

Study Sites (2)

Cancer Hospital/ Institute, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Department of Breast Surgery, Cancer Hospital, Fudan University

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zhiming Shao, M.D

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Model Details: All patients will undergo FES-PET/CT at baseline and FES-PET after 28 days of fulvestrant treatment. Whenever possible, tumor biopsies will be performed to correlate to FES-PET results.

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 24, 2018
• Study Start: September 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: May 8, 2019

Record last verified: 2019-05

Locations

CN (2)