Clinical Application of Circulating Tumor DNA (ctDNA) to Guided the Late-Line Treatment for Patients With Late-Stage Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Control group
- Conditions
- Metastatic Breast Cancer
- Sponsor
- Hunan Cancer Hospital
- Enrollment
- 223
- Primary Endpoint
- Disease Control Rate (DCR)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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 curative effect of ctDNA subtype-guided late-line therapy.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Control group
Control group includes patients without ctDNA abnormality and patients without druggable ctDNA abnormality.
Intervention: Control group
Case group
Case group includes patients with druggable ctDNA abnormality.
Intervention: Case group
Outcomes
Primary Outcomes
Disease Control Rate (DCR)
Time Frame: 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.
Progression-Free Survival
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.
The survival time between the beginning of treatment to death or the progression.