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Recruiting

NCT Number: NCT04278469

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

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

Recruiting

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Key information

Age range

19 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Location status: Recruiting

Location contact

Jungeun Ma

CONTACT

[email protected]

010-7346-2841 ext. 82

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy Drugs, Cancer

Drug

Clinical high and genomic low Hormone Receptor-positive early breast cancer patients with or without adjuvant chemotherapy

Other names: GenesWell™ BCT (analysis genomic risk)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jungeun Ma, master

CONTACT

[email protected]

010-7346-2841 ext. 82

Sponsors and collaborators

Lead sponsor

Gencurix, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
Feb 20, 2020
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.