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

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

Study Overview

• Status: Recruiting
• Conditions: Early Hormone Receptor-positive Breast Cancer
• Intervention / Treatment: Drug: Chemotherapy Drugs, Cancer

• Study Type: Interventional
• Enrollment (Anticipated): 194
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jungeun Ma, master; Phone Number: 82 010-7346-2841; Email: masecret1015@gencurix.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Recruiting
    • Samsung Medical Center
    • Contact: Jungeun Ma; Phone Number: 82 010-7346-2841; Email: masecret1015@gencurix.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Patients with chemotherapy	Drug: Chemotherapy Drugs, Cancer; Clinical high and genomic low Hormone Receptor-positive early breast cancer patients with or without adjuvant chemotherapy; Other Names: GenesWell™ BCT (analysis genomic risk)
NO_INTERVENTION: Patients without chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10-year distant metastasis free survival	To evaluate 10-year distant metastasis free survivals according to adjuvant chemotherapy in patients with clinical high and genomic low risk	up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease free survival	To evaluate 10-year disease free survivals and overall survivals according to adjuvant chemotherapy in patients with clinical high and genomic low risk	up to 10 years
overall survival	To evaluate 10-year disease free survivals and overall survivals according to adjuvant chemotherapy in patients with clinical high and genomic low risk	up to 10 years

Collaborators and Investigators

• Sponsor: Gencurix, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 11, 2019
• Primary Completion (ANTICIPATED): January 1, 2029
• Study Completion (ANTICIPATED): January 1, 2029

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (ACTUAL): February 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Antineoplastic Agents
• Other Study ID Numbers: GCX-BCT-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No