Blood Biomarkers for Breast Cancer Treatment Response (TrackER)
Prospective Plasma Biomarker Study to Predict 2nd Line Endocrine Therapy Response in ER+ Metastatic Breast Cancer (TrackER)
This study looks at whether a simple blood test can help predict how well a breast cancer treatment will work. It follows patients with advanced hormone receptor-positive breast cancer whose cancer has progressed after their first treatment.
Researchers collect a blood sample when patients start a second hormone therapy treatment and may collect additional samples over time. By comparing blood test results with patient outcomes, the study aims to identify biomarkers that can predict which patients are most likely to benefit from treatment.
Přehled studie
Postavení
Detailní popis
This prospective observational study will enroll up to 200 patients with advanced hormone receptor-positive breast cancer whose cancer has progressed after their first treatment. The goal is to evaluate whether a blood-based biomarker, called the PERDI score, can predict how well patients respond to a second line hormone therapy.
Participants will provide a blood sample before starting treatment, with optional additional samples collected during treatment or at disease progression. Researchers will compare the blood test results with clinical outcomes, including how long the cancer remains under control, to determine whether the PERDI score can help identify patients who are most likely to benefit from treatment.
The study will be conducted across multiple sites within a single institution and will run for approximately 18 months, including a 12-month enrollment period and 6 months of follow-up. Findings from this study may help support more personalized treatment decisions and improve outcomes for patients with advanced breast cancer.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Setareh Sharzehi, MD, PhD, MS
- Telefonní číslo: (313) 452-3013
- E-mail: sharzehis@upmc.edu
Studijní záloha kontaktů
- Jméno: Marjia Balic, MD, PhD
- E-mail: balicm@upmc.edu
Studijní místa
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Pennsylvania
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Pittsburgh, Pennsylvania, Spojené státy, 15213
- UPMC/Magee Hospital
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Kontakt:
- Setareh Sharzehi Sharzehi, MD, PhD
- Telefonní číslo: (313) 452-3013
- E-mail: sharzehis@upmc.edu
-
Kontakt:
- Marjia Balic, MD,PHD
- E-mail: balicm@upmc.edu
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Vrchní vyšetřovatel:
- Marjia Balic, MD,PhD
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Dílčí vyšetřovatel:
- Julia Foldi, MD, PhD
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Dílčí vyšetřovatel:
- Adam Brufsky, MD
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Dílčí vyšetřovatel:
- Charles Geyer, MD
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Dílčí vyšetřovatel:
- Vikram Gorantla, MD
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Dílčí vyšetřovatel:
- Monica Molhatra, MD
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Dílčí vyšetřovatel:
- Priya Rastogi, MD
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
All patients with metastatic breast cancer refer to UPMC all sites
Popis
Inclusion Criteria:
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Patients must be ≥18 years of age
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Cytologically or histologically confirmed invasive breast cancer that is:
- Clinical stage IV
- HR positive
- Progressing on first line treatment
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ECOG 0-2
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Locally assessed ER+.
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Locally assessed HER2-negative (IHC 2+/FISH-negative or IHC 0 or 1+ /either FISH-negative or untested).
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No prior chemotherapy
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Must have the ability to understand and the willingness to sign a written informed consent document.
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Must be willing to provide serial blood samples for the study.
Exclusion Criteria:
1. Medical condition or social situation that may preclude adherence to the protocol.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: CASE_ONLY
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
|---|
|
breast cancer stage IV patients
ER+ breast cancer stage IV patients after progression on first line treatment and will continue treatment with second line endocrine therapy |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
To Assess the performance of the baseline PERDI score
Časové okno: From the time between date of first day of 2L ET treatment and date of progression or death, whichever occurs first at 6 months or 1 year
|
Assessment of the performance of the baseline PERDI score, derived from plasma patients collected prior to the start of their second-line endocrine therapy (2L ET) using an epigenomics-based cell-free DNA (cfDNA) profiling assay, in predicting Progression-free survival (PFS). |
From the time between date of first day of 2L ET treatment and date of progression or death, whichever occurs first at 6 months or 1 year
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Assessment of the baseline modified PERDI score
Časové okno: 6 months or 1 year after start 2L therapy
|
Preform a prospective cross-study meta-analysis of both PERDI and modifies PERDI. Progression-free survival (PFS) will be compared between modified PERDI-positive and negative derived from plasma collected at the start of second line therapy using epigenomics- based cfDNA profiling assay. |
6 months or 1 year after start 2L therapy
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Marjia Balic, MD, PhD, University of Pittsburgh
Publikace a užitečné odkazy
Obecné publikace
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- Heitzer E, Haque IS, Roberts CES, Speicher MR. Current and future perspectives of liquid biopsies in genomics-driven oncology. Nat Rev Genet. 2019 Feb;20(2):71-88. doi: 10.1038/s41576-018-0071-5.
- Andre F, Ciruelos E, Rubovszky G, Campone M, Loibl S, Rugo HS, Iwata H, Conte P, Mayer IA, Kaufman B, Yamashita T, Lu YS, Inoue K, Takahashi M, Papai Z, Longin AS, Mills D, Wilke C, Hirawat S, Juric D; SOLAR-1 Study Group. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019 May 16;380(20):1929-1940. doi: 10.1056/NEJMoa1813904.
- Giaquinto AN, Sung H, Miller KD, Kramer JL, Newman LA, Minihan A, Jemal A, Siegel RL. Breast Cancer Statistics, 2022. CA Cancer J Clin. 2022 Nov;72(6):524-541. doi: 10.3322/caac.21754. Epub 2022 Oct 3.
- Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- Turner NC, Oliveira M, Howell SJ, Dalenc F, Cortes J, Gomez Moreno HL, Hu X, Jhaveri K, Krivorotko P, Loibl S, Morales Murillo S, Okera M, Park YH, Sohn J, Toi M, Tokunaga E, Yousef S, Zhukova L, de Bruin EC, Grinsted L, Schiavon G, Foxley A, Rugo HS; CAPItello-291 Study Group. Capivasertib in Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2023 Jun 1;388(22):2058-2070. doi: 10.1056/NEJMoa2214131.
- Bardia A, Cortes J, Bidard FC, Neven P, Garcia-Saenz J, Aftimos P, O'Shaughnessy J, Lu J, Tonini G, Scartoni S, Paoli A, Binaschi M, Wasserman T, Kaklamani V. Elacestrant in ER+, HER2- Metastatic Breast Cancer with ESR1-Mutated Tumors: Subgroup Analyses from the Phase III EMERALD Trial by Prior Duration of Endocrine Therapy plus CDK4/6 Inhibitor and in Clinical Subgroups. Clin Cancer Res. 2024 Oct 1;30(19):4299-4309. doi: 10.1158/1078-0432.CCR-24-1073.
- Cardoso F, Paluch-Shimon S, Schumacher-Wulf E, Matos L, Gelmon K, Aapro MS, Bajpai J, Barrios CH, Bergh J, Bergsten-Nordstrom E, Biganzoli L, Cardoso MJ, Carey LA, Chavez-MacGregor M, Chidebe R, Cortes J, Curigliano G, Dent RA, El Saghir NS, Eniu A, Fallowfield L, Francis PA, Franco Millan SX, Gilchrist J, Gligorov J, Gradishar WJ, Haidinger R, Harbeck N, Hu X, Kaur R, Kiely B, Kim SB, Koppikar S, Kuper-Hommel MJJ, Lecouvet FE, Mason G, Mertz SA, Mueller V, Myerson C, Neciosup S, Offersen BV, Ohno S, Pagani O, Partridge AH, Penault-Llorca F, Prat A, Rugo HS, Senkus E, Sledge GW, Swain SM, Thomssen C, Vorobiof DA, Vuylsteke P, Wiseman T, Xu B, Costa A, Norton L, Winer EP. 6th and 7th International consensus guidelines for the management of advanced breast cancer (ABC guidelines 6 and 7). Breast. 2024 Aug;76:103756. doi: 10.1016/j.breast.2024.103756. Epub 2024 May 28.
- Bidard FC, Mayer EL, Park YH, Janni W, Ma C, Cristofanilli M, Bianchini G, Kalinsky K, Iwata H, Chia S, Fasching PA, Brufsky A, Nowecki Z, Pascual J, Moreau L, Chen SC, Karadurmus N, Gal-Yam EN, Jung KH, Pernas S, McClain S, He W, Klinowska T, Huang-Bartlett C, Turner NC; SERENA-6 Study Group. First-Line Camizestrant for Emerging ESR1-Mutated Advanced Breast Cancer. N Engl J Med. 2025 Aug 7;393(6):569-580. doi: 10.1056/NEJMoa2502929. Epub 2025 Jun 1.
- Turner NC, Im SA, Saura C, Juric D, Loibl S, Kalinsky K, Schmid P, Loi S, Sunpaweravong P, Musolino A, Li H, Zhang Q, Nowecki Z, Leung R, Thanopoulou E, Shankar N, Lei G, Stout TJ, Hutchinson KE, Schutzman JL, Song C, Jhaveri KL. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2024 Oct 31;391(17):1584-1596. doi: 10.1056/NEJMoa2404625.
- Turner NC, Kingston B, Kilburn LS, Kernaghan S, Wardley AM, Macpherson IR, Baird RD, Roylance R, Stephens P, Oikonomidou O, Braybrooke JP, Tuthill M, Abraham J, Winter MC, Bye H, Hubank M, Gevensleben H, Cutts R, Snowdon C, Rea D, Cameron D, Shaaban A, Randle K, Martin S, Wilkinson K, Moretti L, Bliss JM, Ring A. Circulating tumour DNA analysis to direct therapy in advanced breast cancer (plasmaMATCH): a multicentre, multicohort, phase 2a, platform trial. Lancet Oncol. 2020 Oct;21(10):1296-1308. doi: 10.1016/S1470-2045(20)30444-7. Epub 2020 Sep 10.
- Klocker EV, Hasenleithner S, Bartsch R, Gampenrieder SP, Egle D, Singer CF, Rinnerthaler G, Hubalek M, Schmitz K, Bago-Horvath Z, Petzer A, Heibl S, Heitzer E, Balic M, Gnant M. Clinical applications of next-generation sequencing-based ctDNA analyses in breast cancer: defining treatment targets and dynamic changes during disease progression. Mol Oncol. 2025 Jul;19(7):1897-1917. doi: 10.1002/1878-0261.13671. Epub 2024 Jun 12.
- Moser T, Kuhberger S, Lazzeri I, Vlachos G, Heitzer E. Bridging biological cfDNA features and machine learning approaches. Trends Genet. 2023 Apr;39(4):285-307. doi: 10.1016/j.tig.2023.01.004. Epub 2023 Feb 13.
- Tang Y, Li J, Liu B, Ran J, Hu ZY, Ouyang Q. Circulating tumor DNA profile and its clinical significance in patients with hormone receptor-positive and HER2-negative mBC. Front Endocrinol (Lausanne). 2022 Nov 28;13:1075830. doi: 10.3389/fendo.2022.1075830. eCollection 2022.
- Dickinson K, Sharma A, Agnihotram RV, Altuntur S, Park M, Meterissian S, Burnier JV. Circulating Tumor DNA and Survival in Metastatic Breast Cancer: A Systematic Review and Meta-Analysis. JAMA Netw Open. 2024 Sep 3;7(9):e2431722. doi: 10.1001/jamanetworkopen.2024.31722.
- Amato O, Giannopoulou N, Ignatiadis M. Circulating tumor DNA validity and potential uses in metastatic breast cancer. NPJ Breast Cancer. 2024 Mar 12;10(1):21. doi: 10.1038/s41523-024-00626-6.
- Ribnikar D, Volovat SR, Cardoso F. Targeting CDK4/6 pathways and beyond in breast cancer. Breast. 2019 Feb;43:8-17. doi: 10.1016/j.breast.2018.10.001. Epub 2018 Oct 8.
- Basaran GA, Twelves C, Dieras V, Cortes J, Awada A. Ongoing unmet needs in treating estrogen receptor-positive/HER2-negative metastatic breast cancer. Cancer Treat Rev. 2018 Feb;63:144-155. doi: 10.1016/j.ctrv.2017.12.002. Epub 2017 Dec 6.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- STUDY26030107
Plán pro data jednotlivých účastníků (IPD)
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Collaborators may have access to study data only in de-identified or aggregated tabular form for data quality review, consultation on study procedures, or manuscript preparation and will not have access to raw data or participant identifiers. De-identified study specimens and data, including genetic data, may be shared with other researchers, institutions, and/or federal repositories for collaborative research under approved data-sharing agreements. Outside investigators may access de-identified specimens only with approval and collaboration of study investigators. Requests for data or specimens must include a detailed proposal describing the research question, analysis plan, data handling procedures, and variables requested. Specimens will be released only under an approved Material Transfer Agreement, and data only under an approved Data Use Agreement. The master code linking participant identifiers to study data will not be shared.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- ICF
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Studuje lékový produkt regulovaný americkým FDA
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