Metastatic Breast Cancer Clinical Trial
— ACTDNAOfficial title:
Clinical Application of Circulating Tumor DNA (ctDNA) to Monitor the Molecular Tumor Burden in Patients With Late-stage Breast Cancer
NCT number | NCT05079074 |
Other study ID # | 2017YS031 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 1, 2016 |
Est. completion date | June 30, 2021 |
Verified date | June 2022 |
Source | Hunan Cancer Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a retrospective, observational, multi-center clinical study of circulating tumor DNA (ctDNA) application in late-stage breast cancers.
Status | Completed |
Enrollment | 223 |
Est. completion date | June 30, 2021 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | 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: - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hunan Cancer Hospital |
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. — View Citation
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. — View Citation
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. — View Citation
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 Multilin — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ctDNA change index | The dynamic change of the frequency spectrum of ctDNA mutation in plasma. | 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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