Back to resultsClinical High and Genomic Low Hormone Receptor-positive Early Breast Cancer Patients With or Without Adjuvant Chemotherapy
Primary Purpose
Early Hormone Receptor-positive Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Chemotherapy Drugs, Cancer
Sponsored by
About this trial
This is an interventional treatment trial for Early Hormone Receptor-positive Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Adult women aged 19-80 at screening
- Histologically invasive carcinoma
- Hormone receptor positive (Estrogen, ER+ and/or Progesterone, PR+)
- Human epidermal growth factor receptor 2 negative (HER2-)
- Axillary lymph node assessment: pN0 or pN1
- Tumor size≥0.5cm
- Clinical high risk (based on modified Adjuvant! Online)
- Patients who agree to genetic testing
- Patients who have adequate organ function
- Genomic low risk (based on GenesWell BCT)
- De novo primary cancer
- Patients how performed surgery with curative aim
- Patients who have provided written informed consent themselves
Exclusion Criteria:
- Hormone receptor negative (Estrogen, ER- and Progesterone, PR-)
- Human epidermal growth factor receptor 2 positive (HER2+)
- Axillary lymph node assessment: pN2 or pN3
- Patients who are received chemotherapy prior to operation
- Patients who are received radiotherapy prior to operation
- Tumor size<0.5cm
- Clinical low risk
- FFPE tumor sample is not available
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
- Patients who are deemed inappropriate as study participants by investigators
- Patients with recurrent breast cancer or treatment history of breast cancer
- Patients who have not undergone surgery
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Patients with chemotherapy
Patients without chemotherapy
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04278469
Brief Title
Clinical High and Genomic Low Hormone Receptor-positive Early Breast Cancer Patients With or Without Adjuvant Chemotherapy
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
January 2029 (Anticipated)
Study Completion Date
January 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gencurix, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Hormone Receptor-positive Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
194 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with chemotherapy
Arm Type
Active Comparator
Arm Title
Patients without chemotherapy
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Chemotherapy Drugs, Cancer
Other Intervention Name(s)
GenesWell™ BCT (analysis genomic risk)
Intervention Description
Clinical high and genomic low Hormone Receptor-positive early breast cancer patients with or without adjuvant chemotherapy
Primary Outcome Measure Information:
Title
10-year distant metastasis free survival
Description
To evaluate 10-year distant metastasis free survivals according to adjuvant chemotherapy in patients with clinical high and genomic low risk
Time Frame
up to 10 years
Secondary Outcome Measure Information:
Title
disease free survival
Description
To evaluate 10-year disease free survivals and overall survivals according to adjuvant chemotherapy in patients with clinical high and genomic low risk
Time Frame
up to 10 years
Title
overall survival
Description
To evaluate 10-year disease free survivals and overall survivals according to adjuvant chemotherapy in patients with clinical high and genomic low risk
Time Frame
up to 10 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult women aged 19-80 at screening
Histologically invasive carcinoma
Hormone receptor positive (Estrogen, ER+ and/or Progesterone, PR+)
Human epidermal growth factor receptor 2 negative (HER2-)
Axillary lymph node assessment: pN0 or pN1
Tumor size≥0.5cm
Clinical high risk (based on modified Adjuvant! Online)
Patients who agree to genetic testing
Patients who have adequate organ function
Genomic low risk (based on GenesWell BCT)
De novo primary cancer
Patients how performed surgery with curative aim
Patients who have provided written informed consent themselves
Exclusion Criteria:
Hormone receptor negative (Estrogen, ER- and Progesterone, PR-)
Human epidermal growth factor receptor 2 positive (HER2+)
Axillary lymph node assessment: pN2 or pN3
Patients who are received chemotherapy prior to operation
Patients who are received radiotherapy prior to operation
Tumor size<0.5cm
Clinical low risk
FFPE tumor sample is not available
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
Patients who are deemed inappropriate as study participants by investigators
Patients with recurrent breast cancer or treatment history of breast cancer
Patients who have not undergone surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jungeun Ma, master
Phone
010-7346-2841
Ext
82
Email
masecret1015@gencurix.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jungeun Ma
Phone
010-7346-2841
Ext
82
Email
masecret1015@gencurix.com
12. IPD Sharing Statement
Learn more about this trial
Clinical High and Genomic Low Hormone Receptor-positive Early Breast Cancer Patients With or Without Adjuvant Chemotherapy
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