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ACTDNAGLT: Circulating Tumor DNA (ctDNA)-Guided Late-Line Treatment in Patients With Late-Stage Breast Cancer

Sponsor
Hunan Cancer Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05427617
Collaborator
(none)
223
Enrollment
54.9
Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Control group
  • Drug: Case group

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.

Study Design

Study Type:
Observational
Actual Enrollment :
223 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Clinical Application of Circulating Tumor DNA (ctDNA) to Guided the Late-Line Treatment for Patients With Late-Stage Breast Cancer
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Jun 30, 2019
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Control group

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

Drug: Control group
Physician chosen treatment
Case group

Case group includes patients with druggable ctDNA abnormality.

Drug: Case group
Druggable ctDNA alterations-guided therapy
Other Names:
  • PARP inhibtior
  • EGFR inhibitor
  • CDK4/6 inhibitor
  • AR antagonists
  • anti-VEGFR
  • anti-FGFR
  • Fulvestrant
  • ADC drugs
  • PI3K inhibitor
  • anti-HER2 treatment
  • HDAC inhibitor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Disease Control Rate (DCR) [From the beginning of the treatment to the end of Cycle 2 (each cycle is 28 days) of treatment.]

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

    2. Progression-Free Survival [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.]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hunan Cancer Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hunan Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT05427617
    Other Study ID Numbers:
    • KYJJ-2020-022
    First Posted:
    Jun 22, 2022
    Last Update Posted:
    Jun 22, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Fulvestrant
    Histone Deacetylase Inhibitors

    Study Results

    No Results Posted as of Jun 22, 2022