Actively Recruiting
Clinical High and Genomic Low Hormone Receptor-positive Early Breast Cancer Patients With or Without Adjuvant Chemotherapy
Led by Gencurix, Inc. · Updated on 2020-02-20
194
Participants Needed
1
Research Sites
520 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
Clinical High and Genomic Low Hormone Receptor-positive Early Breast Cancer Patients With or Without Adjuvant Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult women aged 19-80 at screening
- Histologically confirmed invasive carcinoma
- Hormone receptor positive (Estrogen, ER+ and/or Progesterone, PR+)
- Human epidermal growth factor receptor 2 negative (HER2-)
- Axillary lymph node status pN0 or pN1
- Tumor size of at least 0.5 cm
- Clinical high risk based on modified Adjuvant! Online
- Agreement to genetic testing
- Adequate organ function
- Genomic low risk based on GenesWell BCT
- De novo primary cancer
- Surgery performed with curative intent
- Written informed consent provided by patient
You will not qualify if you...
- Hormone receptor negative (Estrogen, ER- and Progesterone, PR-)
- Human epidermal growth factor receptor 2 positive (HER2+)
- Axillary lymph node status pN2 or pN3
- Received chemotherapy prior to surgery
- Received radiotherapy prior to surgery
- Tumor size less than 0.5 cm
- Clinical low risk
- FFPE tumor sample unavailable
- Chronic liver disease
- Cerebrovascular disease
- Chronic mental disorder
- Pregnant, breastfeeding, or women of childbearing potential
- Deemed inappropriate by investigators
- Recurrent breast cancer or prior breast cancer treatment
- No surgery performed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, South Korea, 135-710
Actively Recruiting
Research Team
J
Jungeun Ma, master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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