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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
Sponsor:
Information provided by (Responsible Party):
C.P. Schroder, University Medical Center Groningen

Study Description
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Brief 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 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Bicalutamide Procedure: FDHT PET Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Bicalutamide
150mg
Other Name: casodex

Procedure: FDHT PET
PET scan
Other Name: 18F-FDHT PET


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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. 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

  6. 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
  7. Written informed consent

Exclusion Criteria:

  1. Unable to comply with the protocol
  2. Evidence of central nervous metastases
  3. Presence of life-threatening visceral metastases
  4. Corrected QT interval (QTc) >500millliseconds at screening
  5. 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.
  6. Recent history of trombo-embolic events within 6 months prior to screening
  7. Hepatic impairment (Child-Pugh Class B or C)
  8. Severe concurrent disease, infection, co morbid condition that, in the judgment of the investigator would make the patient inappropriate for enrollment
  9. The concomitant use of strong CYP3A4 inhibitors (see table 1)
  10. Previous anti-androgen treatment
  11. Concurrent use of ER-directed anti hormonal therapies
  12. Radiotherapy or major surgery within 4 weeks before baseline PET scanning
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: Carolien P. Schröder, MD, PhD University Medical Center Groningen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by C.P. Schroder, University Medical Center Groningen:
FDHT
PET
Breast cancer
Bicalutamide
Additional relevant MeSH terms:
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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