Advanced Breast CancerGRECO-BNCT04436393
Guardant360® Related Clinical Outcomes in Patients Who Share Medical Records-Breast Cancer
An observational study of Advanced Breast Cancer, run by Guardant Health, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Guardant360 test
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2020to 17 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects located in the United States that have undergone Guardant360 testing as part of their routine clinical care.
Who may be able to join
- 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
Who cannot join
- 1. Unable to understand English
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Advanced Breast Cancer
- Being tested
- Guardant360 test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guardant360 testDiagnostic test
tumor cfDNA testing
| Study group | Role | What they receive |
|---|---|---|
| Advanced Breast Cancer | Patients with diagnosis of advanced breast cancer Receives: Diagnostic Test: Guardant360 test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 18 months post Guardant360 testing
Secondary outcomes (5)
Rate of biomarker discovery
Assess the rate of biomarker discovery compared to tumor genotyping results
Measured: 18 months post Guardant360 testing
Time to Next Treatment
Assess time to next treatment decision compared to tumor genotyping results
Measured: 18 months post Guardant360 testing
Real-world Time to Tumor Progression
Documented tumor progression either clinically or radiologically
Measured: 18 months post Guardant360 testing
Real-world Overall Survival
Date of death per clinical record or secondary sources (e.g. national death registries)
Measured: 18 months post Guardant360 testing
Demographics
Descriptive statistics of patient demographics
Measured: 18 months post Guardant360 testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start2 Jul 2020
- Primary completion17 Mar 2022
- Study completion17 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guardant Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victoria M Raymond, M.S., Principal investigator, Guardant Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436393
- Sponsor's protocol ID
- 01-BR-003
- Acronym
- GRECO-B
- Status last verified
- Jun 2022
- First submitted
- 16 Apr 2020
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guardant360® Related Clinical Outcomes in Patients Who Share Medical Records-Breast Cancer
- ClinicalTrials.gov ID
- NCT04436393
- Acronym / sponsor ID
- GRECO-B / 01-BR-003
- Conditions
- Advanced Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Guardant Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced Breast Cancer | – | Diagnostic Test: Guardant360 testPatients with diagnosis of advanced breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects located in the United States that have undergone Guardant360 testing as part of their routine clinical care.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Unable to understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guardant360 testtumor cfDNA testing | Diagnostic test | Advanced Breast Cancer |
Primary outcome
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.
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.
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)
5 secondary outcomes
Rate of biomarker discovery
Time frame: 18 months post Guardant360 testing
Time to Next Treatment
Time frame: 18 months post Guardant360 testing
Real-world Time to Tumor Progression
Time frame: 18 months post Guardant360 testing
Real-world Overall Survival
Time frame: 18 months post Guardant360 testing
Demographics
Time frame: 18 months post Guardant360 testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria M Raymond, M.S. principal investigator
Guardant Health, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Breast Cancer, run by Guardant Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 18 months post Guardant360 testing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.