OncoMatch/Clinical Trials/NCT05659797
FES BPET-DBT in Newly Diagnosed Breast Cancer
Is NCT05659797 recruiting? Yes, currently enrolling (Jun 2026). This Early Phase 1 trial studies multiple treatments including BPET/DBT imaging and 18F-FES for breast cancer.
Treatment: BPET/DBT imaging · 18F-FES — Patients with newly diagnosed primary estrogen-receptor (ER) positive breast cancer, with at least one breast lesion that is 1.0 cm in diameter or greater, may be eligible for this study. Patients may participate in this study if they are at least 18 years of age. Up to 20 evaluable subjects will participate in a single imaging cohort. Study subjects will undergo imaging of the breast with a novel device combining dedicated Breast Positron Emission Tomography (BPET) and Digital Breast Tomosynthesis (DBT) following intravenous injection of \[18F\]-Fluoroestradiol (FES). This is an observational study; FES-BPET/DBT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the FES-BPET/DBT results, treatment decisions are made by the treating physicians based upon standard clinical imaging.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (positive by immunohistochemistry)
Known ER positive (by immunohistochemistry) breast cancer
Demographics
Prior therapy
Cannot have received: selective estrogen receptor modulator (tamoxifen, raloxifene)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Pennsylvania · Philadelphia, Pennsylvania
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05659797 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior selective estrogen receptor modulator disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 overexpression is a required biomarker for enrollment.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages