Breast Cancer (Advanced/Metastatic)TrackERNCT07860866
Blood Biomarkers for Breast Cancer Treatment Response
An observational study of Breast Cancer (Advanced/Metastatic) and ER Positive, run by University of Pittsburgh at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer (Advanced/Metastatic), ER Positive
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 May 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with metastatic breast cancer refer to UPMC all sites
Who may be able to join
- Patients must be ≥18 years of age
- Cytologically or histologically confirmed invasive breast cancer that is:
- Clinical stage IV
- HR positive
- Progressing on first line treatment
- ECOG 0-2
Show all 11Show fewer
- Locally assessed ER+.
- Locally assessed HER2-negative (IHC 2+/FISH-negative or IHC 0 or 1+ /either FISH-negative or untested).
- No prior chemotherapy
- Must have the ability to understand and the willingness to sign a written informed consent document.
- Must be willing to provide serial blood samples for the study.
Who cannot join
- 1. Medical condition or social situation that may preclude adherence to the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marjia Balic, MD, PhD contact
United States1 site
UPMC/Magee Hospital
Pittsburgh, Pennsylvania, 15213
Setareh Sharzehi Sharzehi, MD, PhD, (313) 452-3013, sharzehis@upmc.edu
Marjia Balic, MD,PHD, balicm@upmc.edu
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Breast Cancer (Advanced/Metastatic), ER Positive
- Keywords
- ER+ metastatic Breast Cancer, Plasma Biomarker, 2nd line Endocrine therapy
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Assess the performance of the baseline PERDI score
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).
Measured: 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
Secondary outcomes (1)
Assessment of the baseline modified PERDI score
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.
Measured: 6 months or 1 year after start 2L therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer (Advanced/Metastatic)Studies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Precede Biosciences
- Responsible party
- Principal investigator, Marija Balic, MD PhD, University of Pittsburgh
- Investigators
- Marjia Balic, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860866
- Sponsor's protocol ID
- STUDY26030107
- Acronym
- TrackER
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.
PubMed 7165009Cardoso 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.
PubMed 38896983Bidard 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.
PubMed 40454637Turner 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.
PubMed 39476340Bardia 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.
PubMed 39087959Turner 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.
PubMed 37256976Turner 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.
PubMed 32919527Andre 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.
PubMed 31091374Klocker 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.
PubMed 38867388Moser 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.
PubMed 36792446Heitzer 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.
PubMed 30410101Tang 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.
PubMed 36518248Giaquinto 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.
PubMed 36190501Dickinson 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.
PubMed 39235812Amato 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.
PubMed 38472216