NCT04278469

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jan 2019Jan 2029

Study Start

First participant enrolled

January 11, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

10 years

First QC Date

February 18, 2020

Last Update Submit

February 19, 2020

Conditions

Early Hormone Receptor-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 10-year distant metastasis free survival

    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 Outcomes (2)

  • disease free survival

    up to 10 years

  • overall survival

    up to 10 years

Study Arms (2)

Patients with chemotherapy

ACTIVE COMPARATOR
Drug: Chemotherapy Drugs, Cancer

Patients without chemotherapy

NO INTERVENTION

Interventions

Chemotherapy Drugs, CancerDRUG

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

Also known as: GenesWell™ BCT (analysis genomic risk)
Patients with chemotherapy

Eligibility Criteria

Age19 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Interventions

Antineoplastic Agents

Intervention Hierarchy (Ancestors)

Therapeutic UsesPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Jungeun Ma, master

CONTACT

010-7346-2841masecret1015@gencurix.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 20, 2020

Study Start

January 11, 2019

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations

KR(1)