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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control group | Drug | Physician chosen treatment |
| |
| Case group |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | The total rate of CR+PR+SD after the completion of two cycles of late-line therapy. | From the beginning of the treatment to the end of Cycle 2 (each cycle is 28 days) of treatment. |
| Progression-Free Survival | The survival time between the beginning of treatment to death or the progression. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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This cohort study recruited consecutive patients with recent progression of metastatic TNBC after multiple lines of chemotherapy or of HR+ or HER2+ metastatic breast cancer after multiple lines of endocrine or targeted therapy.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| D003953 | Diagnosis-Related Groups |
| D000077267 | Fulvestrant |
| D056572 | Histone Deacetylase Inhibitors |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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Peripheral blood lymphocytes (PBL) and plasma
| Drug |
Druggable ctDNA alterations-guided therapy |
|
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D008722 | Methods |
| D011445 | Prospective Payment System |
| D012051 | Reimbursement Mechanisms |
| D007349 | Insurance, Health, Reimbursement |
| D005381 | Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |