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Metastatic Breast CancerACTDNANCT05079074

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

An observational study of Metastatic Breast Cancer and Circulating Tumor DNA, run by Hunan Cancer Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
ctDNA testing
How many people
223 participants
Where
No sites listed yet
Study dates
1 Dec 2016to 30 Jun 2021
Phase
Observational
Are there results?
None posted in the registry

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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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;
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

About this study

Official title: Clinical Application of Circulating Tumor DNA (ctDNA) to Monitor the Molecular Tumor Burden in Patients With Late-stage Breast Cancer

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.

Being tested
ctDNA testing
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ctDNA testingDiagnostic test

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

Study groups in NCT05079074
Study groupRoleWhat they receive
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.
Receives: Diagnostic Test: ctDNA testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ctDNA change index

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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2021
  2. Study start1 Dec 2016
  3. Primary completion30 Jun 2019
  4. Study completion30 Jun 2021

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
223 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05079074
Sponsor's protocol ID
2017YS031
Acronym
ACTDNA
Status last verified
Jun 2022
First submitted
23 Sep 2021
Last updated
22 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

  • 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.

    PubMed 36518248

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Breast Cancer and Circulating Tumor DNA, run by Hunan Cancer Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ctDNA change index (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05079074, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.

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