ACTDNA: Clinical Application of Circulating Tumor DNA (ctDNA) in Patients With Late-stage Breast Cancer
Study Details
Study Description
Brief Summary
This is a retrospective, observational, multi-center clinical study of circulating tumor DNA (ctDNA) application in late-stage breast cancers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
ctDNA testing was performed for late-stage metastatic breast cancer patients to trace their ctDNA abnormality.
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Outcome Measures
Primary Outcome Measures
- ctDNA change index [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.]
The dynamic change of the frequency spectrum of ctDNA mutation in plasma.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Recent progression of TNBC after multiple lines of chemotherapy or of HR+ or HER2+ MBC after multiple lines of endocrine or targeted therapy;
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No available recommendation for the next treatment regimen;
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An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
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An updated, available pathological HR/HER2 status for metastasis;
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According to RECIST 1.1 standard, there should be at least one measurable target lesion;
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The expected survival time is > 3 months;
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Those aged 18-70 years old;
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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
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Signing informed consent;
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Those willing to accept polygenic testing.
Exclusion Criteria:
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Patients with multiple primary tumors;
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Those who are unable to obtain blood samples;
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Those with a history of immunodeficiency or organ transplantation;
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Those with abnormal cardiac function or previous history of myocardial infarction or serious arrhythmia;
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The researchers think it is not suitable to participate in this experiment.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hunan Cancer Hospital
Investigators
- Principal Investigator: Quchang Ouyang, MD, Hunan Cancer Hospital
Study Documents (Full-Text)
More Information
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. Review.
- 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.
- 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.
- 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.
- 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. Review.
- 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, Lønning 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.
- 2017YS031