Breast CancerPhase 2NCT02697032
FDHT PET and Bicalutamide in Metastatic Breast Cancer
A Phase 2 study testing Bicalutamide and FDHT PET in people with Breast Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Rationale: The purpose is to evaluate whether non-invasive in vivo imaging of androgen receptor (AR) presence in metastatic breast cancer patients by means of 18F-fluoro-dihydrotestosterone positron emission tomography (FDHT-PET) can be used to predict (early) treatment response to, and optimal dosing of, the anti… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Bicalutamide and FDHT PET
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2016to 25 Nov 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Postmenopausal status defined as one of the following:
- Age ≥60 years
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- 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
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FDHT-PET to Visualize the Effect on the Androgen Receptor Level by Bicalutamide
Rationale: The purpose is to evaluate whether non-invasive in vivo imaging of androgen receptor (AR) presence in metastatic breast cancer patients by means of 18F-fluoro-dihydrotestosterone positron emission tomography (FDHT-PET) can be used to predict (early) treatment response to, and optimal dosing of, the anti androgen bicalutamide. The ultimate goal is to contribute to optimal selection of breast cancer patients for anti androgen treatment. Objective: Feasibility to detect a diffrence in uptake on 18F-FDHT scan after 6 weeks of treatment with bicalutamide in metastatic breast cancer patients. Secondary Objectives: to describe whether changes in 18F-FDHT tracer uptake after six weeks associates with response to bicalutamide, to describe whether changes in AR availability are different for breast cancer subgroups during treatment with bicalutamide and to describe whether 18F-FDHT tracer uptake is influenced by the amount of AR tumor expression. Study design: This is a single arm, one stage feasibility study, which will be executed in the University Medical Center Groningen, The Netherlands. The primary endpoint of the study is to evaluate the difference in 18F-FDHT uptake in tumor lesions after 6 weeks of bicalutamide treatment in patients with AR-positive metastatic breast cancer. Patients will be treated with bicalutamide until progression or unacceptable toxicity is encountered. Study population: The investigators will include 20 postmenopausal metastatic breast cancer patients with an AR positive, HER2 negative tumor. Patients should be restaged clinically with bone scintigraphy and CT scan within a 6 week timeframe of the PET examinations. Intervention: All patients will receive a baseline FDHT-PET scan and start with bicalutamide treatment 150mg daily. During follow-up patients will receive one FDHT-PET scan after 6 weeks. Treatment with bicalutamide will continue until progression or unacceptable toxicity is encountered. Main study endpoint: The percent difference in 18F-FDHT uptake in tumor lesions after 6 weeks of monotherapy bicalutamide. A minimum decrease of 20% in 18F-FDHT uptake after 6 weeks compared to baseline uptake with an α of 0.05 and a power of 80%, is considered clinical significant.
- Conditions
- Breast Cancer
- Being tested
- Bicalutamide, FDHT PET
- Keywords
- FDHT, PET, Breast cancer, Bicalutamide
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BicalutamideDrug
Also called casodex
150mg
FDHT PETProcedure or surgery
Also called 18F-FDHT PET
PET scan
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | 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. Receives: Drug: Bicalutamide; Procedure: FDHT PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantify residual AR binding sites in metastatic breast cancer
To quantify residual AR binding sites in metastatic breast cancer after 6 weeks of treatment with bicalutamide.
Measured: 6 weeks
Secondary outcomes (3)
determine whether changes in 18F-FDHT uptake
To determine whether changes in 18F-FDHT uptake after 6 weeks associates with response to bicalutamide.
Measured: 6 weeks
Influence amount of AR tumor expression
To determine whether 18F-FDHT tracer uptake is influenced by the amount of AR tumor expression.
Measured: 6 weeks
Difference in changes in AR availability
To determine whether changes in AR availability are different for breast cancer subgroups during treatment with bicalutamide
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, C.P. Schroder, University Medical Center Groningen
- Investigators
- Carolien P. Schröder, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697032
- Sponsor's protocol ID
- NL2015.0704
- Status last verified
- Nov 2019
- First submitted
- 25 Aug 2015
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Boers J, Venema CM, de Vries EFJ, Hospers GAP, Boersma HH, Rikhof B, Dorbritz C, Glaudemans AWJM, Schroder CP. Serial [18F]-FDHT-PET to predict bicalutamide efficacy in patients with androgen receptor positive metastatic breast cancer. Eur J Cancer. 2021 Feb;144:151-161. doi: 10.1016/j.ejca.2020.11.008. Epub 2020 Dec 18.
PubMed 33341447
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FDHT-PET to Visualize the Effect on the Androgen Receptor Level by Bicalutamide
- ClinicalTrials.gov ID
- NCT02697032
- Acronym / sponsor ID
- NL2015.0704
- Conditions
- Breast Cancer
- Keywords
- FDHT, PET, Breast cancer, Bicalutamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: The purpose is to evaluate whether non-invasive in vivo imaging of androgen receptor (AR) presence in metastatic breast cancer patients by means of 18F-fluoro-dihydrotestosterone positron emission tomography (FDHT-PET) can be used to predict (early) treatment response to, and optimal dosing of, the anti androgen bicalutamide. The ultimate goal is to contribute to optimal selection of breast cancer patients for anti androgen treatment. Objective: Feasibility to detect a diffrence in uptake on 18F-FDHT scan after 6 weeks of treatment with bicalutamide in metastatic breast cancer patients. Secondary Objectives: to describe whether changes in 18F-FDHT tracer uptake after six weeks associates with response to bicalutamide, to describe whether changes in AR availability are different for breast cancer subgroups during treatment with bicalutamide and to describe whether 18F-FDHT tracer uptake is influenced by the amount of AR tumor expression. Study design: This is a single arm, one stage feasibility study, which will be executed in the University Medical Center Groningen, The Netherlands. The primary endpoint of the study is to evaluate the difference in 18F-FDHT uptake in tumor lesions after 6 weeks of bicalutamide treatment in patients with AR-positive metastatic breast cancer. Patients will be treated with bicalutamide until progression or unacceptable toxicity is encountered. Study population: The investigators will include 20 postmenopausal metastatic breast cancer patients with an AR positive, HER2 negative tumor. Patients should be restaged clinically with bone scintigraphy and CT scan within a 6 week timeframe of the PET examinations. Intervention: All patients will receive a baseline FDHT-PET scan and start with bicalutamide treatment 150mg daily. During follow-up patients will receive one FDHT-PET scan after 6 weeks. Treatment with bicalutamide will continue until progression or unacceptable toxicity is encountered. Main study endpoint: The percent difference in 18F-FDHT uptake in tumor lesions after 6 weeks of monotherapy bicalutamide. A minimum decrease of 20% in 18F-FDHT uptake after 6 weeks compared to baseline uptake with an α of 0.05 and a power of 80%, is considered clinical significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Drug: Bicalutamide, Procedure: FDHT PETAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
- Postmenopausal status defined as one of the following:
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BicalutamideAlso: casodex150mg | Drug | Patients |
| FDHT PETAlso: 18F-FDHT PETPET scan | Procedure or surgery | Patients |
Primary outcome
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.
3 secondary outcomes
determine whether changes in 18F-FDHT uptake
Time frame: 6 weeks
Influence amount of AR tumor expression
Time frame: 6 weeks
Difference in changes in AR availability
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Derived from this study: PubMed 33341447Boers J, Venema CM, de Vries EFJ, Hospers GAP, Boersma HH, Rikhof B, Dorbritz C, Glaudemans AWJM, Schroder CP. Serial [18F]-FDHT-PET to predict bicalutamide efficacy in patients with androgen receptor positive metastatic breast cancer. Eur J Cancer. 2021 Feb;144:151-161. doi: 10.1016/j.ejca.2020.11.008. Epub 2020 Dec 18.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolien P. Schröder, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bicalutamide and FDHT PET in people with Breast Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quantify residual AR binding sites in metastatic breast cancer (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02697032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019; AzTrials last refreshed its copy on 7 Nov 2026.