NCT05079074

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

2.6 years

First QC Date

September 23, 2021

Last Update Submit

June 16, 2022

Conditions

Metastatic Breast CancerCirculating Tumor DNAGene Abnormality

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

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

ctDNA testingDIAGNOSTIC_TEST

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

Patients with late-stage metastatic breast cancers.

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 23836314BACKGROUND

  • 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.

    PMID: 23484797BACKGROUND

  • 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.

    PMID: 26311728BACKGROUND

  • 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.

    PMID: 26530965BACKGROUND

  • 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.

    PMID: 27168435BACKGROUND

  • 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.

    PMID: 26099045BACKGROUND

  • 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.

    PMID: 29807833RESULT

  • Tang 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.

    PMID: 36518248DERIVED

  • 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.

    PMID: 35875816DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood lymphocytes (PBL) and plasma

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Quchang Ouyang, MD

    Hunan Cancer Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 15, 2021

Study Start

December 1, 2016

Primary Completion

June 30, 2019

Study Completion

June 30, 2021

Last Updated

June 22, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share