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Determinants of Acquired Endocrine Resistance in Metastatic Breast Cancer: A Pilot Study (ENDO-RESIST)

4. maj 2022 opdateret af: Sunnybrook Health Sciences Centre
This is a single-center prospective study involving analysis of circulating tumor DNA (ctDNA) and the gut microbiome in patients with metastatic breast cancer on standard of care endocrine therapy with an aromatase inhibitor in combination with an inhibitor of the cyclin-dependent kinases 4 and 6 (CDK 4/6). Up to 20 patients with Estrogen Receptor positive (ER+), Human Epidermal Growth Factor Receptor 2 negative (HER2-) metastatic breast cancer and Eastern Cooperative Oncology Group (ECOG) performance status 0-1 will be enrolled. This study involves the collection and analysis of patient samples and does not involve therapeutic intervention.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

Endocrine therapies have been associated with an overall survival benefit in breast cancer and are the preferred initial treatment approach in patients with ER+, HER2- metastatic breast cancer. Unfortunately, resistance to endocrine therapies eventually develops in the metastatic setting and metastatic breast cancer remains an incurable disease. Endocrine resistance may develop as a result of alterations in estrogen signaling and metabolism pathways, which may be modulated by gut bacteria. In addition, genomic profiling of archival tissues and circulating tumor DNA (ctDNA) in ER+ breast cancer has identified multiple somatic molecular alterations that may mediate response to endocrine therapies.

This study is designed to identify markers of endocrine resistance in ctDNA and the gut microbiome in patients with ER+ HER2- metastatic breast cancer.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

20

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Rekruttering
        • Sunnybrook Health Sciences Centre
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients with ER positive and HER2 negative metastatic breast cancer planned to initiate on standard of care treatment with an aromatase inhibitor and a CDK 4/6 inhibitor

Beskrivelse

Inclusion Criteria:

  • Sign written and voluntary informed consent
  • Histological confirmation of advanced ER positive and HER2 negative breast cancer.
  • Adult patients at least 18 years of age
  • ECOG performance status equal to 0 or 1
  • Able to provide written informed consent
  • Must be willing to provide blood for ctDNA analysis on study enrollment and at specified study time points
  • Must be willing and able to perform stool sample collection
  • Patients must be suitable, as per their treating physician, for initiation of first line endocrine therapy with an aromatase inhibitor and a CDK 4/6 inhibitor for metastatic disease

Exclusion Criteria:

  • Prior treatment with CDK 4/6 inhibitors in the neoadjuvant or adjuvant setting
  • Use of targeted therapies other than endocrine therapies alone in the neoadjuvant or adjuvant setting
  • Relapse on prior endocrine therapy or within 6 months of discontinuation of prior adjuvant endocrine therapy
  • History of inflammatory bowel disease, chronic diarrhea or malabsorption syndromes and significant prior bowel resection as judged by the study investigator
  • Use of immunosuppressants including steroids within the previous 4 weeks of planned Cycle 1 Day 1 treatment

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to treatment failure
Tidsramme: 12 months
Time from first treatment on study (standard of care aromatase inhibitor and a CDK 4/6 inhibitor) until the date of treatment discontinuation
12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation between specific mutations in ctDNA and in archival tissue samples (where available from prior testing) with time to treatment failure
Tidsramme: 12 months
Identification of mutations in archival tissue samples (where available from prior testing) and sequencing of ctDNA using next generation sequencing panel
12 months
Diversity and composition of the gut microbiome in patients with ER+ HER2- metastatic breast cancer
Tidsramme: 12 months
Analysis of the gut microbiome via 16S rRNA sequencing and metagenomic sequencing of fecal samples at baseline and at development of progressive disease
12 months
Dietary factors and composition of the gut microbiome
Tidsramme: 14 days
Assessment of food intake via dietary questionnaire and correlation with diversity and composition of the gut microbiome
14 days
Overall survival
Tidsramme: 2 years
Time from start of treatment until death
2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sunnybrook Health Sciences Centre

Efterforskere

  • Ledende efterforsker: Rossanna C. Pezo, MD/PhD, Sunnybrook Health Sciences Centre

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. februar 2019

Primær færdiggørelse (Forventet)

31. december 2022

Studieafslutning (Forventet)

31. december 2022

Datoer for studieregistrering

Først indsendt

1. oktober 2020

Først indsendt, der opfyldte QC-kriterier

1. oktober 2020

Først opslået (Faktiske)

8. oktober 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2022

Sidst verificeret

1. maj 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ENDO-RESIST

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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