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.
Full Title of Study: “Clinical Application of Circulating Tumor DNA (ctDNA) to Guided the Late-Line Treatment for Patients With Late-Stage Breast Cancer”
- Study Type: Observational
- Study Design
- Time Perspective: Retrospective
- Study Primary Completion Date: June 30, 2019
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.
- Drug: Control group
- Physician chosen treatment
- Drug: Case group
- Druggable ctDNA alterations-guided therapy
Arms, Groups and Cohorts
- Control group
- Control group includes patients without ctDNA abnormality and patients without druggable ctDNA abnormality.
- Case group
- Case group includes patients with druggable ctDNA abnormality.
Clinical Trial Outcome Measures
- 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.
Participating in This Clinical Trial
- 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.
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Hunan Cancer Hospital
- Provider of Information About this Clinical Study
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