Status:
RECRUITING
Clinical High and Genomic Low Hormone Receptor-positive Early Breast Cancer Patients With or Without Adjuvant Chemotherapy
Lead Sponsor:
Gencurix, Inc.
Conditions:
Early Hormone Receptor-positive Breast Cancer
Eligibility:
FEMALE
19-80 years
Phase:
NA
Brief Summary
A prospective, randomized, comparative study to evaluate efficacy of anticancer chemotherapy in predicting prognosis and determining chemotherapy method in early Hormone Receptor-positive breast cance...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT04278469
Start Date
January 11 2019
End Date
January 1 2029
Last Update
February 20 2020
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710