Breast Cancer Clinical Trial
Strata PATH™ (Precision Indications for Approved Therapies)
StrataPATH™ is a non-randomized, open-label trial designed to explore efficacy and safety of multiple FDA-approved and commercially available cancer therapies in new, biomarker-guided patient populations.
StrataPATH is a non-randomized, open-label trial designed to explore efficacy and safety of multiple FDA-approved and commercially available cancer therapies in new, biomarker-guided patient populations. Aiming to increase clinical benefit for patients, this study will leverage technology advancements, scientific literature, and Strata's real-world evidence to define novel, highly responsive pan-tumor molecular indications for FDA-approved therapies in both the advanced and micro-metastatic settings. Strata will rapidly identify participants who have efficacy signals for possible expansion into adaptive or randomized studies. Enrollment in each drug/biomarker cohort is competitive. Cohorts may be added, changed, or discontinued over the course of the study
To be eligible to participate in this study, an individual must meet each of the criterion below and the criteria indicated in the selected biomarker/drug cohort appendix:
Male or female ≥18 years of age.
Pathologically confirmed solid tumor
Participants must be able to follow study visit schedule and willing to provide up to 20 mL of peripheral blood samples at the indicated time points
Leftover formalin-fixed, paraffin-embedded (FFPE) tumor tissue or historical CGP or RNA profiling test results available for submission
Biomarker positive for the defined cohort
For individuals with treated or stable brain metastases: No evidence of progression for at least 4 weeks prior to consent
Adequate bone marrow, organ function & laboratory parameters as determined by the treating physician
Adequate cardiac function: 8.1) Left ventricular ejection fraction (LVEF) ≥ 50%, 8.2) QTc interval ≤ 470 ms (females) or ≤ 450 ms (males) average preferred
An individual who meets any of the following criteria will be excluded from participation in this study:
Receiving another cancer treatment
Major surgery within 4 weeks prior to study entry
Has received a systemic cancer treatment within 3 weeks of first study dose
Females who are pregnant or nursing or plan to become pregnant or anyone unwilling to use contraception for the duration of treatment
Ongoing toxicity of CTCAE grade ≥2, other than peripheral neuropathy, related to cancer treatment that was completed within 4 weeks of consent
Ongoing peripheral neuropathy of CTCAE grade ≥3
History of stroke including transient ischemic attack (TIA) or acute myocardial infarction within 6 months of consent
Participant has a known history of human immunodeficiency virus (HIV), Hepatitis B or known active Hepatitis C virus infection
Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder
Any other clinically significant medical condition that, in the opinion of the treating physician, makes participation undesirable, including but not limited to ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness.
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