PALbociclib CoLlaborative Adjuvant Study
- 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 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 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.
- 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
- 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.
- Patients receiving concurrent exogenous hormone therapy (topical vaginal estrogen therapy is allowable).
District of Columbia
Salt Lake City
Trial Phase Phase III
Trial Type Treatment
Alliance Foundation Trials, LLC.
- Primary ID AFT-05
- Secondary IDs NCI-2015-02057, 2014-005181-30, ABCSG 42, BIG 14-03, s16-00989
- Clinicaltrials.gov ID NCT02513394