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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
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.
Placebo oral capsule 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.
Epirubicin (90mg/m2, D1) cycled every 14 days for the first 4 cycles.
pCR
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.
Time frame: Through study completion, an average of 1 year.
DFS
Disease-free Survival
Time frame: Following surgery until Year 3
ORR
Objective Response Rate (ORR) during neoadjuvant period
Time frame: Through study completion, an average of 1 year.
AEs
Number and severity of adverse events.Toxicity will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
Time frame: baseline and weekly through 12 months after randomization
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Cyclophosphamide (600mg/m2, D1) cycled every 14 days for the first 4 cycles.
Paclitaxel (80mg/m2, D1) cycled every 14 days for the later 4 cycles.