For a full description of this trial, please go to the listing on www.clinicaltrials.gov
For Medical Personnel
Eligibility Criteria
Hormone receptor positive (HR+) HER2 negative metastatic breast cancer. Cut-off values for positive/negative staining should be as per standard practice in accordance with ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines. Verification of histology is preferred at the time of recurrence and where not possible or necessary in the judgment of the treating physician, the study will accept histology from the initial diagnosis.
Candidate for planned endocrine therapy in combination with 1st use of palbociclib or ribociclib, in the metastatic setting. The planned endocrine partner can be an aromatase inhibitor (letrozole, anastrozole, exemestane) or fulvestrant, selected through patient/provider choice.
Age 65 years or older.
Adequate bone marrow and organ function.
Absolute neutrophil count > 1,000/µL
Platelets > 100,000/µL
Hemoglobin > 9g/dL
Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (participants with documented Gilbert’s disease are allowed total bilirubin up to 5X ULN)
AST /ALT < 3 x institutional ULN, or ≤ 5 x ULN for subjects with documented metastatic disease to the liver
Creatinine < institutional ULN or creatinine clearance > 30 mL/min/1.73 m2 for subjects with creatinine levels above institutional ULN
Baseline QTc < 480 ms (only for ribociclib participants)
Ability to understand and the willingness to sign a written informed consent document.
