Patients will be randomized to one of two treatment arms (1:1 ratio). Dose-Dense neoadjuvant chemotherapy in the first 8 weeks of will be: epirubicin (90mg/m2) and cyclophosphamide (600mg/m2), followed by paclitaxel (80mg / m2) after 8 weeks, cycled every 14 days for total 8 cycles.
Palbociclib will be administered orally as 125mg capsules, daily on a schedule of 3 weeks (21 days) on, 1 week (7 days) off of a 4 week \[28 days\] cycle.
Arm I: Palbociclib combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
Arm II: Placebo combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
Note:
Following completion of study therapy, surgery will be scheduled for 18-20 weeks post-randomization.
Post-surgical treatment will be at the discretion of treating clinician, following postoperative pathology.
After week 16 (end of study therapy) all patients should continue Palbociclib for one year.
Toxicity will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
