Assessment of Functional Status of Estrogen Receptors in Breast Cancer by Positron Emission Tomography
2 other identifiers
interventional
47
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Apr 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 28, 2015
CompletedFirst Submitted
Initial submission to the registry
May 14, 2015
CompletedFirst Posted
Study publicly available on registry
May 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 3, 2019
CompletedResults Posted
Study results publicly available
January 14, 2020
CompletedJanuary 14, 2020
January 1, 2020
3.7 years
May 14, 2015
December 16, 2019
January 13, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Primary Tumor FFNP Uptake Before and After Estradiol Challenge as Measured by Percent Change in Standardized Uptake Value (SUV)
Completion of second FFNP-PET/CT scan (up to 4 weeks)
Change in Secondary Tumor FFNP Uptake Before and After Estradiol Challenge as Measured by Percent Change in Standardized Uptake Value (SUV)
Completion of second FFNP-PET/CT scan (up to 4 weeks)
Secondary Outcomes (1)
Heterogeneity of Tumor FFNP Uptake as Measured by Number of Participants With Heterogenous Response
Completion of second FFNP-PET/CT scan (up to 4 weeks)
Study Arms (1)
Diagnostic FFNP-PET/CT Scan
EXPERIMENTAL* (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
* Will include (1) 18-FDG-PET/CT scan * Will include (2) 18F-FFNP-PET/CT scans
Eligibility Criteria
You may qualify if:
- 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.
- +5 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Publications (1)
Dehdashti F, Wu N, Ma CX, Naughton MJ, Katzenellenbogen JA, Siegel BA. Association of PET-based estradiol-challenge test for breast cancer progesterone receptors with response to endocrine therapy. Nat Commun. 2021 Feb 2;12(1):733. doi: 10.1038/s41467-020-20814-9.
PMID: 33531464DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Farrokh Dehdashti, M.D.
- Organization
- Washington University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Farrokh Dehdashti, M.D.
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2015
First Posted
May 27, 2015
Study Start
April 28, 2015
Primary Completion
January 3, 2019
Study Completion
January 3, 2019
Last Updated
January 14, 2020
Results First Posted
January 14, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share