advanced or metastatic HR-positive HER2-negative breast cancer
Conditions
Interventions
Additional palbpciclib after progression to fulvestrant
Sponsors
Japan Breast Cancer Research Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1st resistration 1.Historically confirm breast cancer 2.Age: 20-80years postmenopausal woman 3.HER2 negative 4.ER and/or PgR positive, HER2 negative 5.Metastatic or locally advanced breast cancer 6.Patients received Fulvestrant as 1st or 2nd line therapy 7.PS 0 - 2 8.Acceptable for chemotherapy for neoadjuvant and adjuvant setting 9.Permit 1 line chemotherapy for metastatic breast cancer. 10.Permit 1 line hormone therapy for metastatic breast cancer before fulvestrant. (There are no including one line that stop or change hormone therapy before resistant, such as switch TAM to AI, AI to TAM as adjuvant Tx, one year or more from stop adjuvant treatment, discontinue hormone therapy base on adverse event.) 11.Excepted that more than 3 month overall survival 12.No concern about measurable disease baced on RECIST 13.Meet the condition necessary for patients within 4 weeks before resistration (1)Neutrophil count: >=1,500/mm3 (2)Platelet count: >=100,000/mm3 (3)Hemoglobin: >=9.0 g/dL (4)Total bilirubin: <=1.5 mg/dL (5)AST(GOT), ALT(GPT): <=2.5 times the ULN (<=5 times in those with liver metastasis) (6)Serum creatinine: <=1.5 mg/dL 14.Informed consent is obtainable 2nd resistration 1.Patients have confirmed failure to Fulvestrant as 1st or 2nd line therapy 2.ECOG PS: 0-2 3.Excepted that more than 3 month overall survival 4.No concern about measurable disease baced on RECIST 5.Meet the condition necessary for patients within 4 weeks before resistration (1)Neutrophil count: >=1,500/mm3 (2)Platelet count: >=100,000/mm 3 (3)Hemoglobin: >=9.0 g/dL (4)Total bilirubin: <=1.5 mg/dL (5)AST(GOT), ALT(GPT): <=2.5 times the ULN (<=5 times in those with liver metastasis) (6)Serum creatinine: <=1.5 mg/dL 6.Having provided voluntary written consent for participation in this study.
Exclusion criteria
Exclusion criteria: 1st resistration 1.Patients received CDK4/6 inhibitor as metastatic therapy 2.Patients have confirmed failure to Fulvestrant 3.Patients received antibiotics, antifungal drug, antiviral drug and treatment for active infection of HBV and HCV. 4.Pregnancy or lactation 5.Brain metastasis and CNS metastatis 6.With another reasons recognized as inadequate to participate in this study by doctors 2nd resistration 1.Brain metastasis and CNS metastatis 2.With another reasons recognized as inadequate to participate in this study by doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival: PFS | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival Overall response rate Time to treatment failure (TTF) Safety Translational Research | — |
Countries
Japan
Contacts
Public ContactJun Fukase
Japan Breast Cancer Research Group (JBCRG) Head office
Outcome results
None listed