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

February 19, 2020 updated by: Gencurix, Inc.

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

194

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: up to 10 years
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
Time Frame: up to 10 years
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
Time Frame: up to 10 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Gencurix, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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