An observational study in Advanced Breast Cancer, sponsored by Guardant Health, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-22.
Sponsored by Guardant Health, Inc. · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 109 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Guardant Health, Inc. is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects located in the United States that have undergone Guardant360 testing as part of their routine clinical care.
Exclusion Criteria:
Patients with diagnosis of advanced breast cancer
Diagnostic Test: Guardant360 test
tumor cfDNA testing
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.
Time frame: 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.
Time frame: 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)
Time frame: 18 months post Guardant360 testing
Rate of biomarker discovery
Assess the rate of biomarker discovery compared to tumor genotyping results
Time frame: 18 months post Guardant360 testing
Time to Next Treatment
Assess time to next treatment decision compared to tumor genotyping results
Time frame: 18 months post Guardant360 testing
Real-world Time to Tumor Progression
Documented tumor progression either clinically or radiologically
Time frame: 18 months post Guardant360 testing
Real-world Overall Survival
Date of death per clinical record or secondary sources (e.g. national death registries)
Time frame: 18 months post Guardant360 testing
Demographics
Descriptive statistics of patient demographics
Time frame: 18 months post Guardant360 testing
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Guardant Health, Inc.