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Cohort 6: Unresectable Stage III/IV Breast - Triple Negative for Breast Cancer

N/A

Recruiting

Research Sponsored by Guardant Health, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 years

Awards & highlights

Summary

The purpose of SIBYL is to generate clinical validity data for the ability of a future version of Guardant360 developed by Guardant Health to measure response to systemic therapy in patients with unresectable advanced solid tumors. It is necessary to collect clinical data points and treatment outcomes in order to demonstrate clinical validity for longitudinal monitoring with ctDNA and correlation of ctDNA dynamics with therapeutic response, as evaluated by standard methods, including RECIST 1.1 and CT scan measurements.

Eligible Conditions

Breast Cancer
Non-Small Cell Lung Cancer
Colorectal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sensitivity of ctDNA to Detect Disease Progression

Secondary study objectives

Lead Time

Progression-Free Survival (PFS)

RECIST Response

Trial Design

6Treatment groups

Experimental Treatment

Group I: Cohort 6: Unresectable Stage III/IV Breast - Triple NegativeExperimental Treatment1 Intervention