Clinical High and Genomic Low Hormone Receptor-positive Early Breast Cancer Patients With or Without Adjuvant Chemotherapy
NCT ID: NCT04278469
Last Updated: 2020-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
194 participants
INTERVENTIONAL
2019-01-11
2029-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Patients with chemotherapy
Chemotherapy Drugs, Cancer
Clinical high and genomic low Hormone Receptor-positive early breast cancer patients with or without adjuvant chemotherapy
Patients without chemotherapy
No interventions assigned to this group
Interventions
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Chemotherapy Drugs, Cancer
Clinical high and genomic low Hormone Receptor-positive early breast cancer patients with or without adjuvant chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
80 Years
FEMALE
No
Sponsors
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Gencurix, Inc.
INDUSTRY
Responsible Party
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Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GCX-BCT-06
Identifier Type: -
Identifier Source: org_study_id
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