Clinical High and Genomic Low Hormone Receptor-positive E... | NCT04278469

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

NCT04278469

Sponsor

Gencurix, Inc.

Status

Recruiting

Last Update Posted

Feb 20, 2020Actual

Enrollment

194Estimated

Phase

Not Applicable

Conditions

Early Hormone Receptor-positive Breast Cancer

Interventions

Chemotherapy Drugs, Cancer

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 11, 2019Actual

Primary Completion Date

Jan 2029Estimated

Completion Date

Jan 2029Estimated

First Submitted Date

Feb 18, 2020

First Submission Date that Met QC Criteria

Feb 19, 2020

First Posted Date

Feb 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2020

Last Update Posted Date

Feb 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

194Estimated

Label	Type	Description	Intervention Names
Patients with chemotherapy	Active Comparator		Drug: Chemotherapy Drugs, Cancer
Patients without chemotherapy	No Intervention

Name	Type	Description	Arm Group Labels	Other Names
Chemotherapy Drugs, Cancer	Drug	Clinical high and genomic low Hormone Receptor-positive early breast cancer patients with or without adjuvant chemotherapy	Patients with chemotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
disease free survival	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses