Systems Biology Guided Therapy for Breast Cancer Positive for Oestrogen Receptor After Aromatase Inhibitor and CDK Inhibition

Study Overview
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Brief Summary
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There are several approved and guideline-recommended treatments for metastatic, estrogen receptor-positive breast cancer that has progressed on an aromatase inhibitor and a CDK4/6 inhibitor. Right now, doctors do not have a good way of choosing between these treatments. Scientists we work with have come up with ways to use the biology of the tumor to try to predict which treatment is best. This study is being done to test if those predictions are right and to learn more about these tumors to design better treatments in the future.

Official Title
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Systems Biology Guided Therapy for Breast Cancer Positive for Oestrogen Receptor After Aromatase Inhibitor and CDK Inhibition

Conditions
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Breast Cancer, Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer

Intervention / Treatment
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* Drug: Drug determined by treating oncologist based on recommendation from systems biology analysis.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic diagnosis of breast cancer Metastatic or incurable Prior treatment with an anastrozole or letrozole and a CDK4/6 inhibitor Progression while on or within 6 months of stopping the CDK4/6 inhibitor At least one lesion amenable to percutaneous biopsy that is not a purely sclerotic bone lesion ECOG 0-2 Age 18 or greater Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines. Exclusion Criteria: Prior treatment within 2 years with fulvestrant, alpelisib, everolimus, or capecitabine Comorbid disease other than breast cancer with a life expectancy of less than 2 years Cancer other than breast cancer that is expected to need treatment within 2 years Platelets < 100,000/microliter INR > 1.5

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open label, interventional
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Drug determined by treating oncologist based on recommendation from systems biology analysis.|All patients will have a biopsy at the beginning of the trial. The biopsy will be sent for DNA sequencing through FoundationOne(clinical test) and RNA profiling at Fulgent(research test) for determination of activation of various oncogenic pathways and phenotypes. The results will be analyzed and a treatment recommendation will be made to the treating physician based on an algorithm.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Turn around time for systems biology analysis |  | 24 months | 
| Response rate to systems biology guided therapy |  | 24 months | 
| Progression free survival base on concordance with recommended treatment |  | 24 months |