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NCT Number: NCT01988324

AR and ER Imaging in Metastatic Breast Cancer

Knowledge of breast cancer estrogen receptor (ER) expression is of major importance in treatment-decision making. Patients with ER-positive tumors can be treated with anti-oestrogen therapy, which has relatively few side effects compared to chemotherapy. Whole-body tumor ER-expression can be visualized by 18F-fluoroestradiol PET imaging (FES-PET). In addition to ER, the androgen receptor (AR) is a potential new target in breast cancer. PET imaging with 18F-fluorodihydrotestosterone (18F-FDHT) may allow visualization of tumor AR-expression. In the current study we will perform FES-PET and FDHT-PET in metastatic breast cancer patients and evaluate the concordance with concurrent biopsies. Molecular imaging of tumor AR- and ER-expression may well be of value for future treatment decision-making.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VU Medical Center, Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Metastatic breast cancer, with at least one known metastasis outside of the liver
  • Presence of a lesion that is safely accessible for tumor biopsy (may be liver lesion)
  • 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)
  • patients age <60 years using an ER-antagonist should have amenorrhea for > 12 months and FSH >24 U/L and LH >14 U/L e. patient age <60 years using LH-RH agonists should continue LH-RH-agonists until after the PET procedures
  • Initially ER-positive tumor histology.
  • ECOG performance status 0-2.
  • Signed written informed consent
  • Able to comply with the protocol

Exclusion criteria

  • Use of estrogen receptor ligands, including tamoxifen, fulvestrant or estrogens, or androgen receptor ligands, during the 6 weeks before entry into the study
  • Life-expectancy ≤ 3 months

Treatment and study plan

FDHT-PET scan

Other

FES-PET scan

Other

CT-scan

Other

Bone scintigraphy

Other

Tumor biopsy

Other

Primary outcomes

  1. Sensitivity/ specificity

    Time frame: within two months

    The concordance between PET (with 18F-FDHT and 18F-FES), and immunohistochemistry (for AR and ER) on concurrent (within 8 weeks) tumor biopsy will be evaluated.

Secondary outcomes

  1. Accuracy

    Time frame: within six weeks

    The number of lesions detected on PET imaging compared to CT-scan and bone scintigraphy.

  2. Inter- and intra-patient variation

    Time frame: within six weeks

    Inter- and intra-patient variation in tumor FDHT and FES-uptake will be calculated.

  3. Inter-observer variation

    Time frame: approximately two months

    Inter-observer variation in FES PET and FDHT PET results in two independent observers.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Androgen Receptor and Estrogen Receptor Imaging in Metastatic Breast Cancer Patients

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2013
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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