- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04579484
Determinants of Acquired Endocrine Resistance in Metastatic Breast Cancer: A Pilot Study (ENDO-RESIST)
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Rossanna C. Pezo, MD/PhD
- Telefonnummer: 416-480-4757
- E-post: rossanna.pezo@sunnybrook.ca
Studieorter
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Ontario
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Toronto, Ontario, Kanada, M4N 3M5
- Rekrytering
- Sunnybrook Health Sciences Centre
-
Kontakt:
- Rossanna C. Pezo, MD/PhD
- Telefonnummer: 416-480-4757
- E-post: rossanna.pezo@sunnybrook.ca
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Time to treatment failure
Tidsram: 12 months
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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
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Correlation between specific mutations in ctDNA and in archival tissue samples (where available from prior testing) with time to treatment failure
Tidsram: 12 months
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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
Tidsram: 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
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12 months
|
Dietary factors and composition of the gut microbiome
Tidsram: 14 days
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Assessment of food intake via dietary questionnaire and correlation with diversity and composition of the gut microbiome
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14 days
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Overall survival
Tidsram: 2 years
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Time from start of treatment until death
|
2 years
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Rossanna C. Pezo, MD/PhD, Sunnybrook Health Sciences Centre
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ENDO-RESIST
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