Guardant360® Related Clinical Outcomes in Patients Who Share Medical Records-Breast Cancer

Completed

• Conditions: Advanced Breast Cancer
• Interventions: Diagnostic Test: Guardant360 test

• Registration Number: NCT04436393
• Lead Sponsor: Guardant Health, Inc.

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.

Study Timeline

• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-06-15
• Study First Posted: 2020-06-18
• Study Start: 2020-07-02
• Primary Completion: 2022-03-17
• Study Completion: 2022-03-17
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-17
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Advanced Breast Cancer	Guardant360 test	Patients with diagnosis of advanced breast cancer

Primary Outcome Measures

Name	Time	Method
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)
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.

Secondary Outcome Measures

Name	Time	Method
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
Real-world Overall Survival	18 months post Guardant360 testing	Date of death per clinical record or secondary sources (e.g. national death registries)

Trial Locations

Locations (1)

Guardant Health; 🇺🇸 Redwood City, California, United States