Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
National Cancer Center, Japan
With
Pfizer
Korean Cancer Study Group
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Women 18 years of age or older with histologically or cytologically proven locally advanced or metastatic breast cancer, not amenable to resection or radiation therapy with curative intent
Documented diagnosis of HR+/HER2- breast cancer
Any menopausal status
Previously untreated with any endocrine therapy for their HR+/HER2- advanced breast cancer; or progressed while on or within 3 month from prior endocrine therapy other than tamoxifen for advanced breast cancer. If patients have adjuvant endocrine therapy, they must satisfy as follows: progressed 12 months or more since prior adjuvant endocrine therapy with tamoxifen; or progressed during or after adjuvant endocrine therapy with an aromatase inhibitor.
Measurable disease or non-measurable disease as defined by RECIST ver.1.1
Eastern Cooperative Oncology Group (ECOG) PS 0-1
Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
You may not be if
Prior treatment with any CDK inhibitor, tamoxifen, everolimus, or agent that inhibits the PI3K-mTOR pathway
Patients with extensive advanced/metastatic, symptomatic visceral disease, or known uncontrolled or symptomatic CNS metastases
Use of strong or moderate CYP3A4 and/or CYP2D6 inhibitors or inducers
Major surgery or any anti-cancer therapy within 2 weeks of randomization
Prior stem cell or bone marrow transplantation
Clareo Health | PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY
