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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