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

  • STATUS
    Recruiting
  • End date
    Jan 29, 2029
  • participants needed
    194
  • sponsor
    Gencurix, Inc.
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Updated on 16 February 2024
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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

Details
Condition Early Hormone Receptor-positive Breast Cancer
Age 19years - 80years
Treatment Chemotherapy Drugs, Cancer
Clinical Study IdentifierNCT04278469
SponsorGencurix, Inc.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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 size0.5cm
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
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