Guardant360® Related Clinical Outcomes in Patients Who Share Medical Records-Breast Cancer (GRECO-B)

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.

Study Overview

• Status: Completed
• Conditions: Advanced Breast Cancer
• Intervention / Treatment: Diagnostic test: Guardant360 test

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 Type: Observational
• Enrollment (Actual): 109

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Guardant Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Advanced Breast Cancer; Patients with diagnosis of advanced breast cancer	Diagnostic test: Guardant360 test; tumor cfDNA testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Guardant Health, Inc.
• Investigators: Principal Investigator: Victoria M Raymond, M.S., Guardant Health

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2020
• Primary Completion (Actual): March 17, 2022
• Study Completion (Actual): March 17, 2022

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 01-BR-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No