18FDHT-PET to visualize the effect on the androgen receptor level by bicalutamide

Phase 1

• Conditions: androgen receptor positive metastatic breast cancer patients; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2015-001634-17-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-22
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>•To describe whether changes in AR availability are different for breast cancer subgroups during treatment with bicalutamide<br>•To describe whether 18F-FDHT tracer uptake is influenced by the amount of AR tumor expression.<br>;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 Outcome Measures

Name	Time	Method
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.<br>• Relation of AR-expression and 18F-FDHT tracer uptake;Timepoint(s) of evaluation of this end point: 4 weeks