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OpenTrials
Completed

NCT Number: NCT04436393

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

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.

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Key information

Conditions

Advanced Breast Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guardant Health

Redwood City, California, 94063, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Unable to understand English

Treatment and study plan

Guardant360 test

Diagnostic Test

tumor cfDNA testing

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Guardant Health, Inc.

Industry

Registry information

Acronym: GRECO-B

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 18, 2020
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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