None listed
Conditions
Interventions
Drug : 1.Capecitabine 500 mg three times a day. Swallow each tablet whole with water within 30 minutes after a meal. Do not cut or crush the tablet.
2.Fulvestrant 500 mg is administered intramuscularl
Sponsors
Kyungpook National University Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Has received a full explanation of the clinical trial and has voluntarily provided written informed consent. 2. On the date of signing the informed consent, is a female, = 19 years old, post-menopausal, and meets one of the following definitions of post-menopausal status: a. A documented history of irreversible surgical infertility due to bilateral oophorectomy. b. A female aged = 60 years. c. A female aged 9 g/dL o Absolute neutrophil count (ANC) = 1.5 × 10?/L o Platelet count (PLT) = 100 × 10?/L (no red-blood-cell transfusion within the past 7 days) 9. Liver function: o Total bilirubin = 2.0 × upper limit of normal (ULN) or = 1.5 × ULN o AST (SGOT) and ALT (SGPT) = 2.5 × ULN (or = 5.0 × ULN if hepatic metastases are present) 10. Renal function o Creatinine clearance (CrCl) calculated by the Cockcroft-Gault equation = 30 mL/min, or o Serum creatinine = 1.5 × ULN 11. Patients with at least one measurable lesion according to RECIST 1.1
Exclusion criteria
Exclusion criteria: 1. Previous treatment with a CDK4/6 inhibitor. 2. Two or more prior lines of hormonal or two or more prior linese cytotoxic chemotherapy. 3. Previous treatment with any other investigational medicinal product (prior to marketing approval) in a clinical trial within 28 days before the first dose of investigational medicinal product. 4. Prior antitumour therapy (cytotoxic, biological, radiotherapy or hormonal therapy, excluding alternative therapies) received within 28 days before the first dose of the investigational medicinal product. However, the following are exceptions: • Medications prescribed for adjuvant/supportive treatment but which may potentially have antineoplastic activity (e.g., Megestrol acetate, bisphosphonates). Such medications must have been initiated at least one week before enrolment in this clinical trial. 5. Presence of unresolved Grade 2 or higher toxicity according to the CTCAE before the first administration of the investigational medicinal product. (excluding alopecia) 6. Uncontrolled active infection (bacterial, viral, or fungal). 7. Patients who have or are currently infected with unregulated HIV, unregulated hepatitis B or hepatitis C However, the following cases are eligible ?In the case of a positive hepatitis B surface antigen (HBsAg), with normal ALT levels, HBV DNA < 2,000 IU/L, and receiving antiviral therapy for prevention of hepatitis B reactivation. ?HBs Ag negative with positive hepatitis B core antibody (IgG anti-HBc), and HBV DNA below the lower limit of quantification. ?Anti-HCV antibody (Anti-HCV Ab) is positive and HCV RNA is below the lower limit of quantification. 8. Unstable angina; congestive heart failure of NYHA class =4; myocardial infarction within 6 months prior to screening; clinically significant uncontrolled arrhythmias. 9. Pulmonary disease with severely impaired lung function (resting oxygen saturation = 90%, vital capacity and diffusing capacity both = 50% of the predicted normal) 10. clinically significant hemoptysis or gastrointestinal bleeding within the past 6 months 11. History of another malignancy within 5 years, except in situ carcinoma or basal/squamous cell carcinoma of the skin; other malignancies eligible if treated with surgery (± radiotherapy) alone and disease-free =5 years. 12. Scheduled for major surgery during the course of the clinical trial. 13. Patients with hypersensitivity to the active ingredient or excipient of the investigational medicinal product. If assigned to the trial arm and to receive capecitabine, patients with hypersensitivity to or a history of allergy to Opadry Pink (03A14309). 14. Patients who have a clinically significant medical or psychiatric disorder, or are otherwise judged by the Investigator to be unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Overall Survival (OS);Disease Control Rate (DCR);Safety | — |
Countries
Korea, Republic of
Contacts
Public ContactIn Hee Lee
Kyungpook National University Medical Center
Outcome results
None listed