Advanced Breast Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTGuardant360 test
tumor cfDNA testing
Sponsors
Guardant Health, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults (18 years of age and older) with a diagnosis of breast cancer 2. Guardant360 test results released to the patient's physician no less than 14 days prior to initial patient contact 3. Patient has previously provided contact information (either email or phone) to Guardant Health 4. Able and willing to complete the electronic informed consent process 5. Must have access to a computer terminal or personal computing device 6. Willingness to consent to the release of medical records
Exclusion criteria
1\. Unable to understand English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 18 months post Guardant360 testing | 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. |
| Progression Events | 18 months post Guardant360 testing | 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. |
| Subject Lost-to-Follow-Up | 18 months post Guardant360 testing | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Real-world Overall Survival | 18 months post Guardant360 testing | Date of death per clinical record or secondary sources (e.g. national death registries) |
| Rate of biomarker discovery | 18 months post Guardant360 testing | Assess the rate of biomarker discovery compared to tumor genotyping results |
| Demographics | 18 months post Guardant360 testing | Descriptive statistics of patient demographics |
| Time to Next Treatment | 18 months post Guardant360 testing | Assess time to next treatment decision compared to tumor genotyping results |
| Real-world Time to Tumor Progression | 18 months post Guardant360 testing | Documented tumor progression either clinically or radiologically |
Countries
United States
Outcome results
None listed