Clinical High and Genomic Low Hormone Receptor-positive Early Breast Cancer Patients With or Without Adjuvant Chemotherapy

• Status: Recruiting
• Trial end date: 2029-01-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gencurix, Inc.
• Treatments: Antineoplastic Agents; Hormones

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