Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Alliance Foundation Trials, LLC.
With
Austrian Breast & Colorectal Cancer Study Group
NSABP Foundation Inc
PrECOG, LLC.
Breast International Group
Pfizer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed informed consent prior to study specific procedures.
Age ≥18 years (or per national guidelines).
Pre- and postmenopausal women or men with Stage II (Stage IIA limited to max. 1000 patients) or Stage III early invasive breast cancer
Patients must have histologically confirmed ER+ and/or PR+, HER2-, early invasive breast cancer.
Patients must have undergone adequate (definitive) breast surgery for the current malignancy.
FFPE tumor tissue block must be confirmed to be received at the central sample repository prior to randomization.
ECOG performance status 0-1.
Patients must be able and willing to swallow and retain oral medication.
Serum or urine pregnancy test must be negative in premenopausal women within 14 days of randomization, or in women with amenorrhea of less than 12 months at time of randomization.
Patients who received neo/adjuvant therapy must be after last dose of chemotherapy and/or biologic therapy and must have sufficient resolution of side effects.
Patients who received breast/axilla/post-mastectomy chest wall radiotherapy must be after last dose of radiotherapy and must have sufficient resolution of side effects.
Patients must have sufficient resolution of any surgical side effects (no active wound healing complications).
Patients must either be initiating or have already started adjuvant hormonal treatment. -
Patients who already received neo/adjuvant endocrine therapy are eligible as long as they are enrolled within 12 months of initial histological diagnosis and after completing no more than 6 months of adjuvant endocrine therapy.
Absolute neutrophil count ≥ 1,500/µL
Platelets ≥ 100,000/ mm3
Hemoglobin ≥ 10g/dL
Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in patients with documented Gilbert's Syndrome.
Aspartate amino transferase (AST or SGOT) and alanine amino transferase (ALT or SGPT) ≤ 1.5 × institutional ULN.
Serum creatinine below the upper limit of the institutional normal range (ULN) or creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with serum creatinine levels above institutional ULN.
You may not be if
Concurrent therapy with other Investigational Products.
Prior therapy with any CDK inhibitor.
History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib.
Patients receiving any medications or substances that are potent inhibitors or inducers of
CYP3A isoenzymes within 7 days of randomization.
Uncontrolled intercurrent illness that would limit compliance with study requirements.
Pregnant women, or women of childbearing potential without a negative pregnancy test within 14 days prior to randomization.
Patients with a history of any malignancy are ineligible
Patients who previously received endocrine therapy within 5 years prior to diagnosis of the current malignancy.
Patients on antiretroviral therapy.
Patients with clinically significant history of any chronic liver disease.
