Early Hormone Receptor-positive Breast Cancer
Conditions
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 cancer patients with clinicopathological high risk and GenesWell™ BCT low risk at multi-center in Korea
Interventions
Clinical high and genomic low Hormone Receptor-positive early breast cancer patients with or without adjuvant chemotherapy
Sponsors
Gencurix, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Adult women aged 19-80 at screening 2. Histologically invasive carcinoma 3. Hormone receptor positive (Estrogen, ER+ and/or Progesterone, PR+) 4. Human epidermal growth factor receptor 2 negative (HER2-) 5. Axillary lymph node assessment: pN0 or pN1 6. Tumor size≥0.5cm 7. Clinical high risk (based on modified Adjuvant! Online) 8. Patients who agree to genetic testing 9. Patients who have adequate organ function 10. Genomic low risk (based on GenesWell BCT) 11. De novo primary cancer 12. Patients how performed surgery with curative aim 13. Patients who have provided written informed consent themselves
Exclusion criteria
1. Hormone receptor negative (Estrogen, ER- and Progesterone, PR-) 2. Human epidermal growth factor receptor 2 positive (HER2+) 3. Axillary lymph node assessment: pN2 or pN3 4. Patients who are received chemotherapy prior to operation 5. Patients who are received radiotherapy prior to operation 6. Tumor size\<0.5cm 7. Clinical low risk 8. FFPE tumor sample is not available 9. 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 10. Patients who are deemed inappropriate as study participants by investigators 11. Patients with recurrent breast cancer or treatment history of breast cancer 12. Patients who have not undergone surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 10-year distant metastasis free survival | up to 10 years | To evaluate 10-year distant metastasis free survivals according to adjuvant chemotherapy in patients with clinical high and genomic low risk |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| disease free survival | up to 10 years | To evaluate 10-year disease free survivals and overall survivals according to adjuvant chemotherapy in patients with clinical high and genomic low risk |
| overall survival | up to 10 years | To evaluate 10-year disease free survivals and overall survivals according to adjuvant chemotherapy in patients with clinical high and genomic low risk |
Countries
South Korea
Contacts
Primary ContactJungeun Ma, master
Outcome results
None listed