Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

The propose of this prospective study focuses on the role of [18F]FES PET imaging in patients with breast cancer who might receive or are receiving hormone therapy. First, we will develop and optimize the radiosynthesis and quality control tests of [18F]FES in conditions that meet good manufacturing practice (GMP) requirements. Secondly, patients with or without metastatic breast cancer will be enrolled for the conduction of human study. [18F]FES PET imaging will be performed on patients before the initiation of hormone therapy to predict the prognosis and therapeutic response to hormone therapy. The [18F]FES PET results will be compared with ER status obtained by immunohistochemical (IHC) staining on surgically obtained specimens. Moreover, in patients with progression of metastatic disease, the [18F]FES PET will be correlated with ESR1 gene mutation, which is one of the mechanisms for resistance to hormone therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Female patients more than twenty years old

• Patients with breast cancer proven by pathology or cytology

• ER status evaluated by immunohistochemical (IHC) staining; Her2 status evaluated by IHC or in-situ hybridization (ISH)

• Patients will receive hormone therapy as adjuvant therapy or treatment of metastatic disease

• Patients with ESR1 gene analysis

• Life expectancy >3 months.

• ECOG performance status 0 to 2

• Hematologic Function：

1. Neutrophil count ≥1.5×109/L

2. Platelet count ≥100×109/L

3. Hemoglobin ≥9.0 g/dL

• Liver Function：

1. Total bilirubin level ≤ 1.5 mg/dL

2. Aspartate transaminase (AST) ≤ 77.5 U/L

3. alanine transaminase (ALT) ≤ 102.5 U/L

4. (1) Albumin > 25 g/dL

• Renal Function：Creatinine ≤ 2.0 mg/dL

Exclusion Criteria:

• Patients with known secondary malignancy other than breast cancer

• Patients not suitable for hormone therapy after clinical assessment

• Patients who received neoadjuvant chemotherapy, radiation or hormone therapy before the operation of newly diagnosed breast cancer

• Patients treated with oral or intravenous cytotoxic agent(s) during the same period of hormone therapy

• Pregnant or planning pregnant woman

• Unclear consciousness

• Allergy to drug

• Cannot accept 18F-FES PET

• Breastfeeding

• There are other tumors

• By doctor evaluation to unsuitable