Circulating Tumor DNA, Gene Abnormality, Metastatic Breast Cancer
Conditions
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.
Interventions
DRUGControl group
Physician chosen treatment
DRUGCase group
Druggable ctDNA alterations-guided therapy
Sponsors
Hunan Cancer Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | 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 | 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. |
Outcome results
None listed