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CompletedNCT05427617ACTDNAGLTUpdated Jun 22, 2022

Circulating Tumor DNA (ctDNA)-Guided Late-Line Treatment 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
Case-control
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) to guide late-line therapy in late-stage metastatic breast cancer patients.

Read the detailed description

This study aims to evaluate the feasibility of plasma ctDNA mutation in guiding late-line treatment for late-stage metastatic breast cancer patients. Meanwhile, this study tries to evaluate the curative effect of ctDNA subtype-guided late-line therapy.

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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
Case-control
Time perspective
Retrospective
Enrollment
223 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Control group

    Control group includes patients without ctDNA abnormality and patients without druggable ctDNA abnormality.

    Drug: Control group

  • Case group

    Case group includes patients with druggable ctDNA abnormality.

    Drug: Case group

Interventions

  • DrugControl group

    Physician chosen treatment

  • DrugCase group

    Druggable ctDNA alterations-guided therapy

    Also known as: PARP inhibtior, EGFR inhibitor, CDK4/6 inhibitor, AR antagonists, anti-VEGFR, anti-FGFR, Fulvestrant, ADC drugs, PI3K inhibitor, anti-HER2 treatment, HDAC inhibitor

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What researchers measure

Primary outcomes

  1. Disease Control Rate (DCR)

    The total rate of CR+PR+SD after the completion of two cycles of late-line therapy.

    Time frame: From the beginning of the treatment to the end of Cycle 2 (each cycle is 28 days) of treatment.

  2. Progression-Free Survival

    The survival time between the beginning of treatment to death or the progression.

    Time frame: From 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

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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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
NCT05427617
Lead sponsor
Hunan Cancer Hospital
Responsible party
Sponsor
First posted
Jun 22, 2022
Start date
Dec 1, 2016
Primary completion
Jun 30, 2019
Completion
Jun 30, 2021
Last update
Jun 22, 2022

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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