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CompletedNCT05079074ACTDNAUpdated Jun 22, 2022

Clinical Application of Circulating Tumor DNA (ctDNA) in Patients With Late-stage Breast Cancer

An observational study in Metastatic Breast Cancer, Circulating Tumor DNA and Gene Abnormality, sponsored by Hunan Cancer Hospital. Completed. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-06-22.

Sponsored by Hunan Cancer Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
223
Ages
18 Years to 70 Years
Sex
Female
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Study summary

This is a retrospective, observational, multi-center clinical study of circulating tumor DNA (ctDNA) application in late-stage breast cancers.

Read the detailed description

This study aims to evaluate the feasibility of plasma ctDNA mutation spectrum and clonal spectrum in late-stage metastatic breast cancer patients. Meanwhile, this study tries to establish a model of ctDNA subtyping system to evaluate the molecular load of tumor, to evaluate the curative effect comprehensively and to detect the disease progression in advance. In addition, the investigators plan to explore the clonal evolution of ctDNA in patients with progressive disease (PD), and to monitor the changes of tumor heterogeneity from the molecular level, so as to provide reference for the analysis of drug sensitivity.

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Conditions studied

  • Metastatic Breast Cancer
  • Circulating Tumor DNA
  • Gene Abnormality

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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 223 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Hunan Cancer Hospital is the lead sponsor of 54 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This cohort study recruited consecutive patients with recent progression of metastatic TNBC after multiple lines of chemotherapy or of HR+ or HER2+ metastatic breast cancer after multiple lines of endocrine or targeted therapy.

Inclusion criteria

  • Recent progression of TNBC after multiple lines of chemotherapy or of HR+ or HER2+ MBC after multiple lines of endocrine or targeted therapy;
  • No available recommendation for the next treatment regimen;
  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
  • An updated, available pathological HR/HER2 status for metastasis;
  • According to RECIST 1.1 standard, there should be at least one measurable target lesion;
  • The expected survival time is > 3 months;
  • Those aged 18-70 years old;
  • Liver and kidney function and blood routine test meet the following conditions: Neutrophil > 2.0g/l, Hb > 9g / L, PLT > 100g / L; ALT and AST \< 2.5ULN; TBIL \< 1.5ULN; Cr \< 1.0ULN
  • Signing informed consent;
  • Those willing to accept polygenic testing.

Exclusion criteria

Exclusion Criteria:

  • Patients with multiple primary tumors;
  • Those who are unable to obtain blood samples;
  • Those with a history of immunodeficiency or organ transplantation;
  • Those with abnormal cardiac function or previous history of myocardial infarction or serious arrhythmia;
  • The researchers think it is not suitable to participate in this experiment.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
223 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients with late-stage metastatic breast cancers.

    This cohort included patients with late-stage metastatic breast cancers and their disease progressed after at least two-line treatment.

    Diagnostic Test: ctDNA testing

Interventions

  • Diagnostic testctDNA testing

    ctDNA testing was performed for late-stage metastatic breast cancer patients to trace their ctDNA abnormality.

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What researchers measure

Primary outcomes

  1. ctDNA change index

    The dynamic change of the frequency spectrum of ctDNA mutation in plasma.

    Time frame: From the date of recruitment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Crowley E, Di Nicolantonio F, Loupakis F, Bardelli A. Liquid biopsy: monitoring cancer-genetics in the blood. Nat Rev Clin Oncol. 2013 Aug;10(8):472-84. doi: 10.1038/nrclinonc.2013.110. Epub 2013 Jul 9. PubMed 23836314 ↗
  • Dawson SJ, Tsui DW, Murtaza M, Biggs H, Rueda OM, Chin SF, Dunning MJ, Gale D, Forshew T, Mahler-Araujo B, Rajan S, Humphray S, Becq J, Halsall D, Wallis M, Bentley D, Caldas C, Rosenfeld N. Analysis of circulating tumor DNA to monitor metastatic breast cancer. N Engl J Med. 2013 Mar 28;368(13):1199-209. doi: 10.1056/NEJMoa1213261. Epub 2013 Mar 13. PubMed 23484797 ↗
  • Garcia-Murillas I, Schiavon G, Weigelt B, Ng C, Hrebien S, Cutts RJ, Cheang M, Osin P, Nerurkar A, Kozarewa I, Garrido JA, Dowsett M, Reis-Filho JS, Smith IE, Turner NC. Mutation tracking in circulating tumor DNA predicts relapse in early breast cancer. Sci Transl Med. 2015 Aug 26;7(302):302ra133. doi: 10.1126/scitranslmed.aab0021. PubMed 26311728 ↗
  • Murtaza M, Dawson SJ, Pogrebniak K, Rueda OM, Provenzano E, Grant J, Chin SF, Tsui DWY, Marass F, Gale D, Ali HR, Shah P, Contente-Cuomo T, Farahani H, Shumansky K, Kingsbury Z, Humphray S, Bentley D, Shah SP, Wallis M, Rosenfeld N, Caldas C. Multifocal clonal evolution characterized using circulating tumour DNA in a case of metastatic breast cancer. Nat Commun. 2015 Nov 4;6:8760. doi: 10.1038/ncomms9760. PubMed 26530965 ↗
  • Swanton C, Govindan R. Clinical Implications of Genomic Discoveries in Lung Cancer. N Engl J Med. 2016 May 12;374(19):1864-73. doi: 10.1056/NEJMra1504688. No abstract available. PubMed 27168435 ↗
  • Yates LR, Gerstung M, Knappskog S, Desmedt C, Gundem G, Van Loo P, Aas T, Alexandrov LB, Larsimont D, Davies H, Li Y, Ju YS, Ramakrishna M, Haugland HK, Lilleng PK, Nik-Zainal S, McLaren S, Butler A, Martin S, Glodzik D, Menzies A, Raine K, Hinton J, Jones D, Mudie LJ, Jiang B, Vincent D, Greene-Colozzi A, Adnet PY, Fatima A, Maetens M, Ignatiadis M, Stratton MR, Sotiriou C, Richardson AL, Lonning PE, Wedge DC, Campbell PJ. Subclonal diversification of primary breast cancer revealed by multiregion sequencing. Nat Med. 2015 Jul;21(7):751-9. doi: 10.1038/nm.3886. Epub 2015 Jun 22. PubMed 26099045 ↗
  • Hu ZY, Xie N, Tian C, Yang X, Liu L, Li J, Xiao H, Wu H, Lu J, Gao J, Hu X, Cao M, Shui Z, Xiao M, Tang Y, He Q, Chang L, Xia X, Yi X, Liao Q, Ouyang Q. Identifying Circulating Tumor DNA Mutation Profiles in Metastatic Breast Cancer Patients with Multiline Resistance. EBioMedicine. 2018 Jun;32:111-118. doi: 10.1016/j.ebiom.2018.05.015. Epub 2018 May 26. PubMed 29807833 ↗
  • Hu ZY, Tang Y, Liu L, Xie N, Tian C, Liu B, Zou L, Zhou W, Wang Y, Xia X, Ouyang Q. Subtyping of metastatic breast cancer based on plasma circulating tumor DNA alterations: An observational, multicentre platform study. EClinicalMedicine. 2022 Jul 18;51:101567. doi: 10.1016/j.eclinm.2022.101567. eCollection 2022 Sep. PubMed 35875816 ↗

Study documents

  • Study protocol · Dec 1, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05079074
Lead sponsor
Hunan Cancer Hospital
Responsible party
Sponsor
First posted
Oct 15, 2021
Start date
Dec 1, 2016
Primary completion
Jun 30, 2019
Completion
Jun 30, 2021
Last update
Jun 22, 2022

Study contacts

Quchang Ouyang, MD
principal investigator · Hunan Cancer Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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