Inclusion Criteria:
- Signed informed consent prior to study specific precedures.
- 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 with multicentric and/or multifocal and/or bilateral early invasive breast
cancer are eligible if all histopathologically examined tumors meet pathologic
criteria for ER+ and/or PR+ and HER2-.
- Patients must have histologically confirmed ER+ and/or PR+, HER2-, early invasive
breast cancer.
- Patients must have undergone 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/L
- 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 within normal institutional limits or creatinine clearance 60
mL/min/1.73 m2 for patients with serum creatinine levels above institutional ULN.
Exclusion Criteria:
- Concurrent therapy with other Investigational Products.
- Prior therapy with any CDK inhibitor.
- Patients with Stage I or IV breast cancer are not eligible.
- 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 (for exceptions see: Pallas -
- Protocol, v1.0, Exclusion criteria 8).
- Patients who previously received endocrine therapy within 5 years prior to diagnosis
of the current malignancy.
- Patients on combination antiretroviral therapy.
- Patients with clinically significant history of any liver disease.
- Patients receiving concurrent exogenous hormone therapy (topical vaginal estrogen
therapy is allowable).
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
