Clinical trial · Interventional
Clinical High and Genomic Low Hormone Receptor-positive Early Breast Cancer Patients With or Without Adjuvant Chemotherapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Hormone Receptor-positive Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy Drugs, Cancer | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Patients with chemotherapy
- interventionNames
- Drug: Chemotherapy Drugs, Cancer
- type
- NO_INTERVENTION
- label
- Patients without chemotherapy
Primary outcomes (1)
- measure
- 10-year distant metastasis free survival
- timeFrame
- up to 10 years
- description
- To evaluate 10-year distant metastasis free survivals according to adjuvant chemotherapy in patients with clinical high and genomic low risk
Secondary outcomes (2)
- measure
- disease free survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available