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

Advanced Breast Cancer Clinical Trial

— GRECO-B  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04436393
• Other study ID #: 01-BR-003
• Status: Completed
• Start date: July 2, 2020
• Est. completion date: March 17, 2022

Study information

• Verified date: June 2022
• Source: Guardant Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: March 17, 2022
• Est. primary completion date: March 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• Guardant360 test
tumor cfDNA testing

Locations

Country	Name	City	State
United States	Guardant Health	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
Guardant Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Rate of biomarker discovery	Assess the rate of biomarker discovery compared to tumor genotyping results	18 months post Guardant360 testing
Secondary	Time to Next Treatment	Assess time to next treatment decision compared to tumor genotyping results	18 months post Guardant360 testing
Secondary	Real-world Time to Tumor Progression	Documented tumor progression either clinically or radiologically	18 months post Guardant360 testing
Secondary	Real-world Overall Survival	Date of death per clinical record or secondary sources (e.g. national death registries)	18 months post Guardant360 testing
Secondary	Demographics	Descriptive statistics of patient demographics	18 months post Guardant360 testing