What this study is
Simplified from ClinicalTrials.govTesting a diagnostic plan that combines a blood test (liquid biopsy) with a follow-up tissue biopsy and genetic testing, to see how useful it is for finding ESR1 gene mutations in adults 18 and older with hormone receptor-positive, HER2-negative breast cancer that has spread.
Read the original summary from ClinicalTrials.gov
This is a prospective, single center, single-arm interventional study to evaluate the clinical utility of protocol-mandated diagnostic testing algorithm incorporating liquid biopsy and reflex tissue biopsy NGS for detection of ESR1 mutations in HR+/HER- metastatic breast cancer.
What's being tested
- FoundationOne® Liquid CDx (F1LCDx)
Intervention · DIAGNOSTIC TEST
Blood test that analyzes cancer-related genes from a single blood draw
- Reflex tissue biopsy
Intervention · DIAGNOSTIC TEST
Reflex tissue biopsy using an Next-generation sequencing (NGS) test
Study details
- Official title
- Prospective Study to Evaluate the Clinical Utility of ctDNA Tumor Fraction (TF) for Detection of ESR1 Mutations in HR-positive HER2-negative Metastatic Breast Cancer (MBC)
- Sponsor
- Yale University
- Conditions
- Breast Cancer · Metastatic Breast Cancer · HR+/HER- Metastatic Breast Cancer
- Enrolling
- 155 people
- Starts
- 2026-11
- Est. completion
- 2031-10
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Diagnosis of metastatic breast cancer that is hormone receptor-positive (ER≥10%), HER2 low or negative (defined as HER2 Imunohistochemistry (IHC) 0, 1+ or IHC 2+/In Situ Hybridization (ISH)-).
- Progression of metastatic breast cancer that is hormone receptor-positive (ER≥10%), HER2 low or negative (defined as HER2 IHC 0, 1+ or IHC 2+/ISH-) while on systemic therapy.
- Currently receiving or have previously received aromatase inhibitor therapy.
You can't join if
- Patients with locally or regionally recurrent breast cancer without evidence of metastatic disease.
- De novo metastatic breast cancer.
- Presence of symptomatic metastatic visceral crisis.
- Participants with inflammatory breast cancer.
- Intact uterus with a history of endometrial intraepithelial neoplasia (atypical endometrial hyperplasia or higher-grade lesion).
- Diagnosis of any other malignancy within 5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or second primary breast cancer.
- Other conditions that, in the opinion of the treating investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results.
- Pregnant and breastfeeding women are excluded from the study
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openYale New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, United States
Study team
Sponsor
Yale University
Study ID 2000038562
Principal investigator
Jing Du, MD
Yale University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.