Circulating Tumor DNA (ctDNA)-Guided Late-Line Treatment in Patients With Late-Stage Breast Cancer (NCT05427617) | Clinical Trial Compass
CompletedNot Applicable
Circulating Tumor DNA (ctDNA)-Guided Late-Line Treatment in Patients With Late-Stage Breast Cancer
223 participantsStarted 2016-12-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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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.
What they're measuring
1
Disease Control Rate (DCR)
Timeframe: From the beginning of the treatment to the end of Cycle 2 (each cycle is 28 days) of treatment.
2
Progression-Free Survival
Timeframe: 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.