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Prospective Study to Evaluate the Clinical Utility of ctDNA Tumor Fraction (TF) for Detection of Estrogen Receptor 1 (ESR1) Mutations in (Human Epidermal Growth Factor Receptor) HR+/HER2- Metastatic Breast Cancer (MBC)

2 november 2026 bijgewerkt door: Yale University

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)

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Participants are prospectively assigned to undergo ctDNA testing with FoundationOne® Liquid CDx (F1LCDx) at protocol-defined clinical decision points. Participants with an indeterminate negative F1LCDx result (ctDNA TF <1% and negative for ESR1mut) are assigned to undergo reflex tissue biopsy NGS unless deemed medically unsafe. The protocol does not mandate treatment selection; treating clinicians retain full discretion regarding therapy.All research-related procedures will be performed at the time of standard of care clinical visits. No extra visits outside of routine care are required. For participants with algorithm-detected ESR1 mutations, serial Electronic Medical Record review will be performed for up to 2 years to track subsequent treatment patterns, progression events, and survival status to assess other clinical outcomes associated with subsequent SERD-based regimens compared with historical clinical trial benchmarks.

This study will guide clinical decision-making for acquiring new tissue specimens following an indeterminate negative ESR1mut result from liquid biopsy, which is a critical step to ensure accurate detection of actionable mutations and enable the selection of the most appropriate targeted therapy

Studietype

Ingrijpend

Inschrijving (Geschat)

155

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Connecticut
      • New Haven, Connecticut, Verenigde Staten, 06520
        • Yale New Haven Hospital - Yale Cancer Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: HR+/HER- metastatic breast cancer at diagnosis or experiencing disease progression

Participants with ESR1 mutations in HR+/HER- metastatic breast cancer undergoing tissue biopsy for ctDNA Tumor Fraction (TF) testing using next-generation sequencing (NGS) after an indeterminate negative result in liquid biopsy (F1LCDx).
Diagnostische toets: FoundationOne® Liquid CDx (F1LCDx)

Blood test that analyzes cancer-related genes from a single blood draw

Diagnostische toets: Reflex tissue biopsy

Reflex tissue biopsy using an Next-generation sequencing (NGS) test

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of participants with ESR1 mutations detected by reflex tissue NGS
Tijdsspanne: From enrollment through study completion (up to 5 years)

Among participants with an indeterminate-negative liquid biopsy result (negative for ESR1 mutations and ctDNA tumor fraction below 1%), measure the number of participants with an ESR1 mutation detected by reflex tissue NGS performed according to the study algorithm.
From enrollment through study completion (up to 5 years)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-free survival (PFS)
Tijdsspanne: Up to 2 years after positive ESR1 mutation detection

Time from initiation of the first selective estrogen receptor degrader (SERD) after ESR1 mutation detection until objective disease progression, assessed using RECIST version 1.1 when available, or death from any cause, whichever occurs first.
Up to 2 years after positive ESR1 mutation detection
Rate of ESR1 mutation detection by liquid biopsy and ctDNA tumor fraction
Tijdsspanne: Throughout the study, up to 5 years

Rate of ESR1 mutation detection by FoundationOne Liquid CDx (F1LCDx), stratified by ctDNA tumor fraction below 1% versus 1% or greater.
Throughout the study, up to 5 years
Reflex Tissue NGS testing rate
Tijdsspanne: Within the reflex testing time frame during the study, up to 5 years

Number of participants with an indeterminate-negative liquid biopsy result who undergo reflex tissue biopsy and NGS within the protocol-defined timeframe.
Within the reflex testing time frame during the study, up to 5 years
Number participants initiating Selective Estrogen Receptor Degraders (SERD) therapy
Tijdsspanne: Throughout the study, up to 5 years

Number participants initiating SERD therapy after ESR1 mutation detection
Throughout the study, up to 5 years
Number participants SERD therapy by SERD agent
Tijdsspanne: Throughout the study, up to 5 years

Number participants initiating SERD therapy after ESR1 mutation detection. Report counts by SERD agent, with FDA-approved SERDs grouped by class as applicable.
Throughout the study, up to 5 years
Actionable genomic alterations detected by liquid biopsy and tissue NGS.
Tijdsspanne: Throughout the study, up to 5 years

Rtes of actionable genomic alterations detected by F1LCDx and tissue NGS.
Throughout the study, up to 5 years
Other genomic alterations detected at disease progression
Tijdsspanne: At disease progression during the study, up to 5 years

Rates of driver and acquired genomic alterations detected at progression by F1LCDx or tissue NGS that were absent from prior tissue comprehensive genomic profiling (CGP). Acquired alterations are those absent from tissue CGP at diagnosis but newly detected at progression.
At disease progression during the study, up to 5 years
Correlation of HRR gene findings with variant origin and germline confirmation
Tijdsspanne: During the study, when the relevant genomic and confirmatory testing results are available, up to 5 years

Assess the relationship between homologous recombination repair (HRR) gene detection, variant origin prediction, germline banner classification when F1LCDx is performed, and confirmation of germline alterations by orthogonal testing.
During the study, when the relevant genomic and confirmatory testing results are available, up to 5 years
Correlation of HER2 status with ERBB2 copy number
Tijdsspanne: During the study, when the relevant HER2 status and genomic results are available, up to 5 years

Assess the relationship between HER2-low or HER2-negative status and ERBB2 copy number results when F1CDx is performed.
During the study, when the relevant HER2 status and genomic results are available, up to 5 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Yale University

Medewerkers

Foundation Medicine

Onderzoekers

  • Hoofdonderzoeker: Jing Du, MD, Yale University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

1 oktober 2031

Studie voltooiing (Geschat)

1 oktober 2031

Studieregistratiedata

Eerst ingediend

26 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 oktober 2026

Eerst geplaatst (Werkelijk)

2 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2000038562

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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