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.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Setareh Sharzehi, MD, PhD, MS
- Puhelinnumero: (313) 452-3013
- Sähköposti: sharzehis@upmc.edu
Tutki yhteystietojen varmuuskopiointi
- Nimi: Marjia Balic, MD, PhD
- Sähköposti: balicm@upmc.edu
Opiskelupaikat
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Pennsylvania
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Pittsburgh, Pennsylvania, Yhdysvallat, 15213
- UPMC/Magee Hospital
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Ottaa yhteyttä:
- Setareh Sharzehi Sharzehi, MD, PhD
- Puhelinnumero: (313) 452-3013
- Sähköposti: sharzehis@upmc.edu
-
Ottaa yhteyttä:
- Marjia Balic, MD,PHD
- Sähköposti: balicm@upmc.edu
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Päätutkija:
- Marjia Balic, MD,PhD
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Alatutkija:
- Julia Foldi, MD, PhD
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Alatutkija:
- Adam Brufsky, MD
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Alatutkija:
- Charles Geyer, MD
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Alatutkija:
- Vikram Gorantla, MD
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Alatutkija:
- Monica Molhatra, MD
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Alatutkija:
- Priya Rastogi, MD
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
All patients with metastatic breast cancer refer to UPMC all sites
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: CASE_ONLY
- Aikanäkymät: PROSPECTIVE
Kohortit ja interventiot
Ryhmä/Kohortti |
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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 |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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To Assess the performance of the baseline PERDI score
Aikaikkuna: 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
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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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Assessment of the baseline modified PERDI score
Aikaikkuna: 6 months or 1 year after start 2L therapy
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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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Marjia Balic, MD, PhD, University of Pittsburgh
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
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- 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.
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- 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.
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Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
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Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- STUDY26030107
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- ICF
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