androgen receptor positive metastatic breast cancer patients
Conditions
Interventions
Product Name: 16-beta-[18F]fluoro-5-alpha-dihydrotestosterone
Product Code: 18F-FDHT
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: TESTOSTERONE
Other descriptive name: fluorodyhidrot
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A history of histological proven AR-positive (i.e. >10% staining), HER2-negative metastatic breast cancer (preferably assessment on fresh metastasis biopsy, alternatively archival metastasis biopsy) 2. Tumor progression after at least one line of systemic treatment 3. Measurable disease according to RECIST 1.1; or evaluable disease 4. Age = 18 years 5. Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Unable to comply with the protocol. 2. Evidence of central nervous metastases 3. Presence of life-threatening visceral metastases 4. Severe concurrent disease, infection, co morbid condition that, in the judgment of the investigator would make the patient inappropriate for enrollment 5. Clinical significant cardiovascular disease (no NYHA class >2, myocardial infarction within 6 months, uncontrolled angina within 3 months, history of clinical significant ventricular arrhythmias, history of Mobitz II second or third degree heart block, uncontrolled hypertension (systolic blood pressure > 150 mmHg, diastolic blood pressure > 105 mmHg) 6. Previous anti-androgen treatment 7. Concurrent use of ER-directed anti hormonal therapies 8. Toxicity of radiotherapy or major surgery before baseline PET scanning
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Feasibility to detect a difference in uptake on 18F-FDHT scan after 4 weeks of treatment with bicalutamide in metastatic breast cancer patients.;Secondary Objective: •To describe whether changes in 18F-FDHT uptake after 4 weeks associates with response to bicalutamide. •To describe whether changes in AR availability are different for breast cancer subgroups during treatment with bicalutamide •To describe whether 18F-FDHT tracer uptake is influenced by the amount of AR tumor expression. ;Primary end point(s): The percentage difference in 18F-FDHT uptake in tumor lesions after 4 weeks of monotherapy bicalutamide.;Timepoint(s) of evaluation of this end point: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •The difference in change in 18F-FDHT uptake after 4 weeks between those patients with a response and those without response. • Relation of AR-expression and 18F-FDHT tracer uptake;Timepoint(s) of evaluation of this end point: 4 weeks | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Medical Oncology
University Medical Center Groningen
Outcome results
None listed