Clinical High and Genomic Low Hormone Receptor-positive Early Breast Cancer Patients With or Without Adjuvant Chemotherapy
Recruiting · NCT04278469 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Chemotherapy Drugs, Cancer
What this trial is about
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
Who can take part
Age range
19 Years to 80 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Samsung Medical Center - Seoul, South Korea