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

Gencurix

Status: Enrolling

Conditions: Early Hormone Receptor-positive Breast Cancer

Treatments: Drug: Chemotherapy Drugs, Cancer

Study type: Interventional

Funder types: Industry

Identifiers

NCT04278469

GCX-BCT-06

Details and patient eligibility

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

Enrollment: 194 estimated patients

Sex: Female

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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194 participants in 2 patient groups

Patients with chemotherapy

Active Comparator group

Treatment:

Drug: Chemotherapy Drugs, Cancer

Patients without chemotherapy

No Intervention group