Early Hormone Receptor-positive Breast CancerNCT04278469
Clinical High and Genomic Low Hormone Receptor-positive Early Breast Cancer Patients With or Without Adjuvant Chemotherapy
A study testing Chemotherapy Drugs, Cancer in people with Early Hormone Receptor-positive Breast Cancer, run by Gencurix, Inc. at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 80 years, women only
- Conditions the study is for
- Early Hormone Receptor-positive Breast Cancer
- What is being tested?
- Chemotherapy Drugs, Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Jan 2019to Jan 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Jungeun Ma, 010-7346-2841 ext. 82, masecret1015@gencurix.com
About this study
Official 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
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
- Being tested
- Chemotherapy Drugs, Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy Drugs, CancerDrug
Also called GenesWell™ BCT (analysis genomic risk)
Clinical high and genomic low Hormone Receptor-positive early breast cancer patients with or without adjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Patients with chemotherapy | Active comparator | Not described Receives: Drug: Chemotherapy Drugs, Cancer |
| Patients without chemotherapy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 10 years
Secondary outcomes (2)
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
Measured: up to 10 years
overall survival
To evaluate 10-year disease free survivals and overall survivals according to adjuvant chemotherapy in patients with clinical high and genomic low risk
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start11 Jan 2019
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Hormone Receptor-positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gencurix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278469
- Sponsor's protocol ID
- GCX-BCT-06
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No