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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04436393
Recruitment Status : Recruiting
First Posted : June 18, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Guardant Health, Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Advanced Breast Cancer 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 Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Guardant360® Related Clinical Outcomes in Patients Who Share Medical Records-Breast Cancer
Actual Study Start Date : July 2, 2020
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Advanced Breast Cancer
Patients with diagnosis of advanced breast cancer
 Diagnostic Test: Guardant360 test
tumor cfDNA testing


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 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.


  2. Progression Events [ Time Frame: 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.


  3. Subject Lost-to-Follow-Up [ Time Frame: 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)



Secondary Outcome Measures :
  1. Rate of biomarker discovery [ Time Frame: 18 months post Guardant360 testing ]
    Assess the rate of biomarker discovery compared to tumor genotyping results

  2. Time to Next Treatment [ Time Frame: 18 months post Guardant360 testing ]
    Assess time to next treatment decision compared to tumor genotyping results

  3. Real-world Time to Tumor Progression [ Time Frame: 18 months post Guardant360 testing ]
    Documented tumor progression either clinically or radiologically

  4. Real-world Overall Survival [ Time Frame: 18 months post Guardant360 testing ]
    Date of death per clinical record or secondary sources (e.g. national death registries)

  5. Demographics [ Time Frame: 18 months post Guardant360 testing ]
    Descriptive statistics of patient demographics


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04436393


Contacts
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Contact: Aaron Fuchs, M.B.S. (650) 618-8226 GRECO@guardanthealth.com

Locations
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United States, California
Guardant Health Recruiting
Redwood City, California, United States, 94063
Contact: Victoria Raymond    650-618-8226    GRECO@guardanthealth.com   
Sponsors and Collaborators
Guardant Health, Inc.
Investigators
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Principal Investigator: Victoria M Raymond, M.S. GUARDANT HEALTH
More Information
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Responsible Party: Guardant Health, Inc.
ClinicalTrials.gov Identifier: NCT04436393    
Other Study ID Numbers: 01-BR-003
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases