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

Not Applicable

Recruiting

• Conditions: Early Hormone Receptor-positive Breast Cancer
• Interventions: Drug: Chemotherapy Drugs, Cancer

• Registration Number: NCT04278469
• Lead Sponsor: Gencurix, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-11
• Status Verified: 2020-02
• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-19
• Last Update Submitted: 2020-02-19
• Study First Posted: 2020-02-20
• Last Update Posted: 2020-02-20
• Primary Completion: 2029-01
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 194

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with chemotherapy	Chemotherapy Drugs, Cancer	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of