None listed
Conditions
Interventions
Drug, Medical Device : Palbociclib at a dose of 125 mg will be administered orally once a day for 21 days, followed by 7 days off treatment of every 28 day cycle. Investigational medicinal product (IM
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for this trial, patients have to comply with the following eligibility criteria: 1. Patient is an adult, = 19 years old at the time of informed consent 2. Premenopausal and postmenopausal women or men with primary invasive breast cancer 3. De novo primary disease 4. Patient who performed surgery with curative aim 5. Patient who has negative surgical resection margins 6. Patient with histologically confirmed HER2-negative breast cancer 7. Patient with histologically confirmed ER positive breast cancer by local laboratory testing 8. Pathological node assessment: pN0 or pN1 9. Tumor size = 0.5 cm, and T1 or T2 10. Clinical High-Risk (Clinical high-risk patients as per the modified Adjuvant! Online guideline in the clinical trial MINADCT(Microarray in Node Negative Disease May Avoid Chemotherapy), refer to section 5.2.1) 11. Genomic High-Risk in BCT score (= 4) 12. Patients agreed to use effective contraception or not be of childbearing potential. 13. Patient has adequate bone marrow and organ function - adequate bone marrow function(= ANC 1,500/uL, = Hemoglobin 9.0g/dL) - adequate kidney function(= serum creatinie 1.5mg/dL or CCr = 50mL/min) - adequate liver function(= serum bilirubin 2.0mg/dL, =3 x ULN of AST/ALT) 14. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status = 1 15. Patient who is able to swallow and retain oral medication 16. A FFPE tumor sample must be available for inclusion. The tumor sample must be taken from the excised primary tumor ? For RNA extraction, Tumor cellularity percentage on the H&E stained slide = 30% ? Tumor surface area on the H&E stained slide = 3 mm2
Exclusion criteria
Exclusion criteria: To be eligible for this trial, patients must not meet any of the following criteria: 1. Patient with recurred breast cancer 2. Patient with histologically confirmed ER negative 3. Patient with histologically confirmed HER2-positive 4. pN2 or pN3 5. Patient who has received neoadjuvant chemotherapy or endocrine therapy 6. Patient who has received preoperative treatment with CDK 4/6 inhibitors. 7. Patient has received preoperative radiation therapy 8. Tumor size less than 0.5 cm 9. Patient with low clinical risk group 10. Patient who low BCT risk group (BCT score<4) 11. Patients with lactose intolerance (example: galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, and so on) 12. Patients with a hypersensitivity to IP and/or components of IP 13. Patients with co-administration of anastrozole 14. Pregnant women, women of childbearing potential or lactating women 15. Patient who has serious underlying co-morbidities which could cause end-organ dysfunction – In case of severe uncontrolled infections - In case of serious medical and mental illness including active heart diseases such as myocardial infarction, angina, uncontrolled arrhythmia within 6 months – In case of having secondary primary malignant tumor – In case of having a medical history of clinically significant liver disease, current alcohol abuse or hepatitis B virus or Known active infection with hepatitis C virus – Immunoactive or HIV-infected 16. A FFPE tumor sample is not available ? The tumor cellularity on the H&E stained slide < 30% ? The tumor surface area on the H&E stained slide < 3 mm2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year EFS(Event free survival) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Performance analysis of BCT score (of GenesWell™ BCT) about predicting the effectiveness of IP;Prognostic and predictive effects of BCT score (of GenesWell™ BCT) as a biomarker to determine the efficacy of palbociclib in combination with endocrine therapy in adjuvant setting in T1-2N0-1 high risk ER+ EBC;Toxicity;Quality of Life (QoL);Exploratory analysis of genomic biomarkers;IP compliance | — |
Countries
Korea, Republic of
Contacts
Public ContactYeon Hee Park
Samsung Medical Center
Outcome results
None listed