FDHT PET and Bicalutamide in Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT02697032 |
Recruitment Status :
Completed
First Posted : March 3, 2016
Last Update Posted : November 27, 2019
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Drug: Bicalutamide Procedure: FDHT PET | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | FDHT-PET to Visualize the Effect on the Androgen Receptor Level by Bicalutamide |
Actual Study Start Date : | February 2016 |
Actual Primary Completion Date : | November 25, 2019 |
Actual Study Completion Date : | November 25, 2019 |

Arm | Intervention/treatment |
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Experimental: Patients
At day 0 before start with bicalutamide, a FDHT-PET/CT will be performed, and one after 6 weeks (i.e. 2 weeks after steady-state). The second FDHT-PET will be performed to determine if this scan can be used as a biomarker for early response. Patients will be treated with bicalutamide until progression or unacceptable toxicity is encountered.
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Drug: Bicalutamide
150mg
Other Name: casodex Procedure: FDHT PET PET scan
Other Name: 18F-FDHT PET |
- quantify residual AR binding sites in metastatic breast cancer [ Time Frame: 6 weeks ]To quantify residual AR binding sites in metastatic breast cancer after 6 weeks of treatment with bicalutamide.
- determine whether changes in 18F-FDHT uptake [ Time Frame: 6 weeks ]To determine whether changes in 18F-FDHT uptake after 6 weeks associates with response to bicalutamide.
- Influence amount of AR tumor expression [ Time Frame: 6 weeks ]To determine whether 18F-FDHT tracer uptake is influenced by the amount of AR tumor expression.
- Difference in changes in AR availability [ Time Frame: 6 weeks ]To determine whether changes in AR availability are different for breast cancer subgroups during treatment with bicalutamide

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
- Tumor progression after at least one line of systemic treatment
- Measurable disease according to RECIST 1.1; or evaluable disease
- Age ≥ 18 years
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Postmenopausal status defined as one of the following:
- Age ≥60 years
- Previous bilateral oophorectomy
- Age <60 years and amenorrhea for >12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists
- Age <60 years using ER antagonists should have amenorrhea for >12 months and FSH >24U/L and LH>14U/L
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Adequate hematological, renal and liver function as follows:
- Absolute neutrophil count > 1.5 x 109/L
- Platelet count >100 x 109/L
- White blood cell count >3 x 109/L
- AST and ALT <3.0 x upper limit of normal (ULN)
- Alkaline phosphatase <2.5 x ULN
- Creatinine clearance >50mL/min
- Lipase/amylase <1/5 x ULN
- Protrombin time, partial tromboplastin time and INR <1.5 x ULN
- Written informed consent
Exclusion Criteria:
- Unable to comply with the protocol
- Evidence of central nervous metastases
- Presence of life-threatening visceral metastases
- Corrected QT interval (QTc) >500millliseconds at screening
- Recent history of cardiac disease, including myocardial infarction, unstable angina pectoris or uncontrolled arrhythmia within 6 months prior to screening; or evidence of severe congestive heart failure with New York Heart Association severity classification > class I.
- Recent history of trombo-embolic events within 6 months prior to screening
- Hepatic impairment (Child-Pugh Class B or C)
- Severe concurrent disease, infection, co morbid condition that, in the judgment of the investigator would make the patient inappropriate for enrollment
- The concomitant use of strong CYP3A4 inhibitors (see table 1)
- Previous anti-androgen treatment
- Concurrent use of ER-directed anti hormonal therapies
- Radiotherapy or major surgery within 4 weeks before baseline PET scanning

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697032
Netherlands | |
University Medical Center Groningen | |
Groningen, Netherlands, 9713 GZ |
Principal Investigator: | Carolien P. Schröder, MD, PhD | University Medical Center Groningen |
Responsible Party: | C.P. Schroder, Principal investigator, University Medical Center Groningen |
ClinicalTrials.gov Identifier: | NCT02697032 |
Other Study ID Numbers: |
NL2015.0704 |
First Posted: | March 3, 2016 Key Record Dates |
Last Update Posted: | November 27, 2019 |
Last Verified: | November 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
FDHT PET Breast cancer Bicalutamide |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Bicalutamide |
Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents |