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

NCT04436393 | Completed

• 1 other identifier: 01-BR-003
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• Rate of biomarker discovery

  18 months post Guardant360 testing

• Time to Next Treatment

  18 months post Guardant360 testing

• Real-world Time to Tumor Progression

  18 months post Guardant360 testing

• Real-world Overall Survival

  18 months post Guardant360 testing

• Demographics

  18 months post Guardant360 testing

Study Arms (1)

Advanced Breast Cancer

Patients with diagnosis of advanced breast cancer

Diagnostic Test: Guardant360 test

Interventions

Guardant360 test DIAGNOSTIC_TEST

tumor cfDNA testing

Advanced Breast Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects located in the United States that have undergone Guardant360 testing as part of their routine clinical care.

You may qualify if:

• Adults (18 years of age and older) with a diagnosis of breast cancer
• Guardant360 test results released to the patient's physician no less than 14 days prior to initial patient contact
• Patient has previously provided contact information (either email or phone) to Guardant Health
• Able and willing to complete the electronic informed consent process
• Must have access to a computer terminal or personal computing device
• Willingness to consent to the release of medical records

You may not qualify if:

• \. Unable to understand English

Sponsors & Collaborators

• Guardant Health, Inc.: lead

Study Sites (1)

Guardant Health

Redwood City, California, 94063, United States

Location

Study Officials

• Victoria M Raymond, M.S.

  Guardant Health, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: June 18, 2020
• Study Start: July 2, 2020
• Primary Completion: March 17, 2022
• Study Completion: March 17, 2022
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)