Breast Cancer Clinical Trial
Official title:
A Randomized Study Evaluating the Safety and Effects of the Combination of Palbociclib With Epirubicin and Cyclophosphamide Followed by Paclitaxel as Neoadjuvant Therapy in Triple Negative Breast Cancer
This study will look at effects the combination of palbociclib and dose-dense neoadjuvant chemotherapy may have on triple negative breast cancer tumours which have not yet been treated.
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).
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