Clinical High and Genomic Low Hormone Receptor-positive Early Breast Cancer Patients With or Without Adjuvant Chemotherapy

Study Overview
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Brief Summary
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A prospective, randomized, comparative study to evaluate efficacy of anticancer chemotherapy in predicting prognosis and determining chemotherapy method in early Hormone Receptor-positive breast cancer patients with clinicopathological high risk and GenesWell™ BCT low risk at multi-center in Korea

Official Title
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A Prospective, Randomized, Comparative Study to Evaluate Efficacy of Anticancer Chemotherapy in Predicting Prognosis and Determining Chemotherapy Method in Early Hormone Receptor-positive Breast Cancer Patients With Clinicopathological High Risk and GenesWell™ BCT Low Risk at Multi-center in Korea

Conditions
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Early Hormone Receptor-positive Breast Cancer

Intervention / Treatment
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* Drug: Chemotherapy Drugs, Cancer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult women aged 19-80 at screening Histologically invasive carcinoma Hormone receptor positive (Estrogen, ER+ and/or Progesterone, PR+) Human epidermal growth factor receptor 2 negative (HER2-) Axillary lymph node assessment: pN0 or pN1 Tumor size≥0.5cm Clinical high risk (based on modified Adjuvant! Online) Patients who agree to genetic testing Patients who have adequate organ function Genomic low risk (based on GenesWell BCT) De novo primary cancer Patients how performed surgery with curative aim Patients who have provided written informed consent themselves Exclusion Criteria: Hormone receptor negative (Estrogen, ER- and Progesterone, PR-) Human epidermal growth factor receptor 2 positive (HER2+) Axillary lymph node assessment: pN2 or pN3 Patients who are received chemotherapy prior to operation Patients who are received radiotherapy prior to operation Tumor size<0.5cm Clinical low risk FFPE tumor sample is not available Patients with following conditions: Patient with chronic liver disease Patient with cerebrovascular disease Patient with chronic mental disorder Pregnant women, women of childbearing potential or lactating women Patients who are deemed inappropriate as study participants by investigators Patients with recurrent breast cancer or treatment history of breast cancer Patients who have not undergone surgery

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients with chemotherapy<br> | Drug: Chemotherapy Drugs, Cancer<br>* Clinical high and genomic low Hormone Receptor-positive early breast cancer patients with or without adjuvant chemotherapy<br>* Other names: GenesWell™ BCT (analysis genomic risk);|
| No Intervention: Patients without chemotherapy<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10-year distant metastasis free survival | To evaluate 10-year distant metastasis free survivals according to adjuvant chemotherapy in patients with clinical high and genomic low risk | up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival | To evaluate 10-year disease free survivals and overall survivals according to adjuvant chemotherapy in patients with clinical high and genomic low risk | up to 10 years | 
| overall survival | To evaluate 10-year disease free survivals and overall survivals according to adjuvant chemotherapy in patients with clinical high and genomic low risk | up to 10 years |