Status:

COMPLETED

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

Lead Sponsor:

Hunan Cancer Hospital

Conditions:

Metastatic Breast Cancer

Circulating Tumor DNA

Eligibility:

FEMALE

18-70 years

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.

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 curati...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

December 1 2016

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 30 2021

Estimated Enrollment :

223 Patients enrolled

Trial Details

Trial ID

NCT05427617

Start Date

December 1 2016

End Date

June 30 2021

Last Update

June 22 2022

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