Actively Recruiting

Phase Not Applicable
Age: 19Years - 80Years
FEMALE
NCT04278469

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

Age: 19Years - 80Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Samsung Medical Center

Seoul, South Korea, 135-710

Actively Recruiting

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