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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 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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

Studientyp

Interventionell

Einschreibung (Geschätzt)

155

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Connecticut
      • New Haven, Connecticut, Vereinigte Staaten, 06520
        • Yale New Haven Hospital - Yale Cancer Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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).
Diagnosetest: FoundationOne® Liquid CDx (F1LCDx)

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

Diagnosetest: Reflex tissue biopsy

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of participants with ESR1 mutations detected by reflex tissue NGS
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression-free survival (PFS)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Yale University

Mitarbeiter

Foundation Medicine

Ermittler

  • Hauptermittler: Jing Du, MD, Yale University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. November 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2031

Studienabschluss (Geschätzt)

1. Oktober 2031

Studienanmeldedaten

Zuerst eingereicht

26. Oktober 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Oktober 2026

Zuerst gepostet (Tatsächlich)

2. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2000038562

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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