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New treatment option for Early Hormone Receptor-positive Breast Cancer
Official title Clinical High and Genomic Low Hormone Receptor-positive Early Breast Cancer Patients With or Without Adjuvant Chemotherapy
ClinicalTrials.gov ID: NCT04278469
What this study is testing
What is Chemotherapy Drugs, Cancer?
Chemotherapy Drugs, Cancer is an investigational medicine, being studied as a potential treatment for early hormone receptor-positive breast cancer.
Also referred to as GenesWell™ BCT (analysis genomic risk).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 80, women only
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 19 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.