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Assessment of Functional Status of Estrogen Receptors in Breast Cancer by Positron Emission Tomography

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ClinicalTrials.gov Identifier: NCT02455453
Recruitment Status : Recruiting
First Posted : May 27, 2015
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE May 14, 2015
First Posted Date  ICMJE May 27, 2015
Last Update Posted Date February 12, 2019
Actual Study Start Date  ICMJE April 28, 2015
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2019)
Change in tumor FFNP uptake before and after estradiol challenge [ Time Frame: Completion of second FFNP-PET/CT scan (up to 4 weeks) ]
As assessed by one or more of the following: changes in standardized uptake value (SUV), tumor to muscle ratio, and / or tumor to background ratio
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2015)
Change in tumor FFNP uptake before and after estradiol challenge [ Time Frame: 3 years ]
As assessed by one or more of the following: changes in standardized uptake value (SUV), tumor to muscle ratio, and / or tumor to background ratio
Change History Complete list of historical versions of study NCT02455453 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2019)
Heterogeneity of tumor FFNP uptake [ Time Frame: Completion of second FFNP-PET/CT scan (up to 4 weeks) ]
As measured visually in known lesion by recording presence or absence of uptake with note of any changes between scans
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2015)
Heterogeneity of tumor FFNP uptake [ Time Frame: 3 years ]
As measured visually in known lesion by recording presence or absence of uptake with note of any changes between scans
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Functional Status of Estrogen Receptors in Breast Cancer by Positron Emission Tomography
Official Title  ICMJE Assessment of Functional Status of Estrogen Receptors in Breast Cancer by Positron Emission Tomography
Brief Summary

The purpose of this study is to evaluate the uptake of a radioactive tracer 21-18F-fluoro-16α,17α-[(R)-(1'-α-furylmethylidene)dioxy]-19-norpregn-4-ene-3,20-dione (FFNP) uptake, which binds to breast cancer progesterone receptors (PgRs) on a PET/CT scan before and after administration of estradiol for one day (estrogen challenge) to determine if the change in uptake is a predictor of response to endocrine therapy (ET) in patients with hormone-sensitive estrogen receptor positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Estradiol is the most potent of the naturally occurring estrogens, and can be administered to treat menopausal symptoms and also sometimes to treat metastatic breast cancer. The investigators propose to study patients with biopsy-proven newly diagnosed, locally advanced, metastatic, or recurrent breast cancer who are going to be treated with endocrine therapy (ET) (tamoxifen,aromatase inhibitors or fulvestrant as standard of care therapy.

Subjects will undergo a total of two FFNP-PET/CT scans; one before and a second one immediately following the one day estradiol challenge before the start of standard of care ET. The estradiol challenge will consist of administering a total of 6 mg of estradiol orally (three doses of 2 mg each) given at approximately 8 hour intervals and over a 24 hour period.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: 18F-FFNP
    Other Name: 21-18F-fluoro-16α,17α-[(R)-(1'-α-furylmethylidene)dioxy]-19-norpregn-4-ene-3,20-dione
  • Device: CTI/Siemens Biograph 40 PET/CT Scanner
    • Will include (1) 18-FDG-PET/CT scan
    • Will include (2) 18F-FFNP-PET/CT scans
  • Drug: Estradiol
  • Drug: 18F-FDG
Study Arms  ICMJE Experimental: Diagnostic FFNP-PET/CT Scan
  • (2) 18F-FFNP-PET/CT scans

    • First one prior to estradiol challenge test
    • Second one immediately following one day of estradiol challenge test
  • (1) FDG-PET/CT scan at screening
  • The estradiol challenge test will consist of administering a total of 6 mg of estradiol dosed orally as three 2 mg tablets with each tablet being administered approximately 8 hours apart and within a 24 hour period. This estradiol medication will be provided to the patient by the study.
Interventions:
  • Drug: 18F-FFNP
  • Device: CTI/Siemens Biograph 40 PET/CT Scanner
  • Drug: Estradiol
  • Drug: 18F-FDG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2015)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2019
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient must be postmenopausal defined as meeting one or more of the following:

    • Age ≥ 60 years
    • Amenorrheic for at least 12 months
    • Surgically sterile- having undergone bilateral oophorectomy,
    • FSH level in postmenopausal range according to institutional standards (note follicle-stimulating hormone (FSH) laboratory testing must be ordered as standard of care to determine optimal treatment and should not be ordered simply to confirm eligibility to this study)
    • OR Pre-menopausal for whom standard estradiol treatment (ET) is planned with ovarian suppression (imaging on study should be completed prior to start of ovarian suppression)
  • Patient must have histological or cytological confirmed breast cancer and fall into one of the following categories:

    • New diagnosis with plans for at least 6 months of neoadjuvant ET or any amount of neoadjuvant ET if surgery is planned as this will be used for response assessment .
    • Patients with newly diagnosed metastatic breast cancer or patient with known metastatic disease who has progressed while on therapy (no washout period is needed if the patient was treated with AIs or chemotherapy, but 2 months washout period is needed if the patient was treated with tamoxifen) who are going to be treated with ET.
  • Patient must have any one of the following types of breast cancer (primary or metastatic): ER+/PgR+/HER2- or ER+/PgR-/HER2-.

    • ER+ is defined as Allred score of at least 4 and greater.
    • PgR+ is defined as Allred score of at least 4 and greater.
    • Immunohistochemistry (IHC) is the primary assay methodology for HER2. HER2- refers to HER2 of 0, 1+ by IHC or negative by fluorescence in situ hybridization (FISH)
  • Patient must have at least one measurable lesion according to RECIST 1.1 by radiological evaluation (ultrasound, mammography, MRI, CT, PET) or physical examination.

    • Patients with evaluable osseous metastasis that are lytic or mixed lytic-sclerotic are eligible.
    • Patients with hepatic lesions may be eligible provided the location of the lesion is peripheral or not too close to hepatic ducts. Decision on hepatic lesion eligibility will be made by the principal investigator or sub-investigator after careful review of all available imaging to ensure evaluation of the lesion will not be obscured by normal hepatobiliary excretion of 18F-FFNP.
  • Patient must be able to understand and willing to sign a written informed consent document.
  • Prior chemotherapy or endocrine therapy is allowed
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or, based on the judgment of the treating medical oncologist, can tolerate imaging and at least 6 months of ET
  • The patient should have a life expectancy of > 6 months.

Exclusion Criteria:

  • Patient with other invasive malignancies, with the exception of non-melanoma skin cancer or cervical carcinoma in-situ, who had (or have) any evidence of the other cancer present within the last 5 years
  • Unable to tolerate up to 60 min of PET imaging per imaging session.
  • Patients with non-measurable non-evaluable lesions such as pleural effusion are not eligible to participate.
  • Patients with vertebral lesions that, in the opinion of the Principal Investigator and the treating medical oncologist, pose an imminent risk for cord compression.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Farrokh Dehdashti, M.D. 314-747-1604 dehdashtif@wustl.edu
Contact: Jennifer Frye, CNMT, PET, CCRC 314-747-1604 fryej@wustl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02455453
Other Study ID Numbers  ICMJE 201411005
5R01CA195450-03 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Farrokh Dehdashti, M.D. Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP