Evaluating chemotherapy in early hormone receptor-positive breast cancer patients
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
This study is testing if chemotherapy can help women with early hormone receptor-positive breast cancer who are at high clinical risk but low genomic risk, to improve their treatment options and outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 194 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | Female |
| Sponsor | Gencurix, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04278469 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy of chemotherapy in predicting prognosis and determining treatment methods for early hormone receptor-positive breast cancer patients who are at high clinical risk but low genomic risk. It is a prospective, randomized, comparative study conducted across multiple centers in Korea. Participants will be adult women diagnosed with invasive carcinoma who meet specific eligibility criteria, including hormone receptor positivity and adequate organ function. The study will involve genetic testing to further stratify risk and guide treatment decisions.
Who should consider this trial
Good fit: Ideal candidates are adult women aged 19-80 with histologically confirmed invasive hormone receptor-positive breast cancer and specific clinical and genomic risk profiles.
Not a fit: Patients with hormone receptor-negative breast cancer or those who have received prior chemotherapy or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for early hormone receptor-positive breast cancer patients, potentially improving outcomes.
How similar studies have performed: Other studies have shown promise in using genomic profiling to guide treatment decisions in breast cancer, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Jungeun Ma, master
- Email: masecret1015@gencurix.com
- Phone: 010-7346-2841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.