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The purpose of this study is to observe the routine clinical care of patients who have been diagnosed with breast cancer and have undergone Guardant360 testing.
Patients who have been diagnosed with breast cancer and have undergone Guardant360 testing will be approached regarding participation in the study. After being informed about the study and potential risks, all patients providing informed consent and access to their medical records, will provide a list of their health care providers related to their cancer treatment. Data related to their routine clinical care will be abstracted from medical records.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced Breast Cancer | Patients with diagnosis of advanced breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guardant360 test | Diagnostic Test | tumor cfDNA testing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The Primary Outcome measure is a composite endpoint of: overall survival, progression events, and subjects lost-to-follow-up Overall Survival is the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. | 18 months post Guardant360 testing |
| Progression Events | The Primary Outcome measure is a composite endpoint of: overall survival, progression events, and subjects lost-to-follow-up Progression events (or progression-free survival) is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. | 18 months post Guardant360 testing |
| Subject Lost-to-Follow-Up | The Primary Outcome measure is a composite endpoint of: overall survival, progression events, and subjects lost-to-follow-up The length of time from date of study consent to date subject exited study prematurely due being considered lost-to-follow-up (ex. lack of response following consent) | 18 months post Guardant360 testing |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of biomarker discovery | Assess the rate of biomarker discovery compared to tumor genotyping results | 18 months post Guardant360 testing |
| Time to Next Treatment | Assess time to next treatment decision compared to tumor genotyping results |
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Inclusion Criteria:
Exclusion Criteria:
1. Unable to understand English
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Subjects located in the United States that have undergone Guardant360 testing as part of their routine clinical care.
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| Name | Affiliation | Role |
|---|---|---|
| Victoria M Raymond, M.S. | Guardant Health, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guardant Health | Redwood City | California | 94063 | United States |
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| 18 months post Guardant360 testing |
| Real-world Time to Tumor Progression | Documented tumor progression either clinically or radiologically | 18 months post Guardant360 testing |
| Real-world Overall Survival | Date of death per clinical record or secondary sources (e.g. national death registries) | 18 months post Guardant360 testing |
| Demographics | Descriptive statistics of patient demographics | 18 months post Guardant360 testing |