Clinical trial · Interventional
FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer
Imaging Early Response of ER+, HER2- Breast Cancer to Aromatase Inhibitor (AI) +/- Ovarian Suppression (OS) Therapy With [18F]Fluorothymidine (FLT) PET
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET) in measuring treatment response in patients with newly diagnosed estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage I-III breast cancer. Comparing results of diagnostic procedures done before and during hormone therapy may help doctors predict a patient's response to treatment and help plan the best treatment.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Estrogen Receptor Positive | — | UNRESOLVED | — |
| HER2/Neu Negative | — | UNRESOLVED | — |
| Male Breast Carcinoma | Male Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorothymidine F-18 | Drug | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
| Run-in (short pre-surgery course) of endocrine-targeted therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (FLT PET)
- description
- Patients undergo FLT PET at baseline and 1-6 weeks after the start of treatment.
- interventionNames
- Drug: Fluorothymidine F-18
- Procedure: Positron Emission Tomography
- Other: Laboratory Biomarker Analysis
- Drug: Run-in (short pre-surgery course) of endocrine-targeted therapy
Primary outcomes (4)
- measure
- Percent Change in Net Influx Constant (Ki) by FLT PET
- timeFrame
- Baseline to up to 6 weeks
- description
- Percent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed. Association between Ki-67 and Ki by FLT (KFLT) decline will be analyzed using the mid-P adjustment to Fisher's exact test to evaluate the potential clinical utility of change in FLT as a biomarker for early response, using Ki-67 as the standard for early response.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * A new diagnosis of invasive breast cancer \> 1.0 cm in size, ER+ clinical stage I-III * Patient must have surgical resection followed by systemic adjuvant therapy with an aromatase inhibitor (AIs) as part of planned treatment; any approved AI at standard clinical dosing may be used; in pre-menopausal patients, ovarian suppression with a gonadotropin-releasing hormone (GnRH) agonist will be started prior to initiation of the AI on a separate clinical trial in parallel with the imaging study * Have tissue block available from core biopsy for correlative biomarkers and genomic assay * Have menopausal status determined prior to study enrollment; for study purposes, postmenopausal is defined as * A prior documented bilateral oophorectomy, or * A history of at least 12 months without spontaneous menstrual bleeding, or * Age 60 or older with a prior hysterectomy without oophorectomy, or * Age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown) with a documented follicle-stimulating hormone (FSH) level demonstrating confirmatory elevation in the postmenopausal range for the lab * Negative pregnancy test within 7 days of baseline positron emission tomography (PET) scan for pre-menopausal patients * Tumor HER2/neu expression must be determined (as part of standard clinical care) prior to study enrollment; HER2 may be tested by any Food and Drug Administration (FDA) approved HER2 testing method; if determination is intermediate by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) or another alternate HER2 test must be performed * Be a candidate for \[18F\]FLT PET imaging * Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening procedures * Be willing and able to comply with scheduled visits and other trial procedures Exclusion Criteria: * Current use of aromatase inhibitor as prevention or treatment for breast cancer * Life expectancy of less than two months * HER2/neu positive by IHC and/or another FDA approved HER2 testing method * Inability to tolerate scanning (e.g. - claustrophobia, severe pain) * Weight exceeding capacity of imaging table
References
Publications (0)
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