This is a Phase II study trying to identify whether short term treatment with PD0332991 yields anti-proliferative response -defined by a low level of Ki67 expression (IHC) at surgery- or induces senescence as determined by SABG expression (IHC) in tumors from patients with early breast cancer non-candidates for neoadjuvant hormonotherapy or chemotherapy, as compared to no treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Gustave Roussy
Villejuif, Val de Marne, France
Anti proliferative response
percentage of patients who at Day 15 have a natural logarithm of percentage positive IHC staining Ki67 of \<1 for each study drug (Ki67 "absolute" antiproliferative responders).
Time frame: Assessed at Day 15 after randomization
Dose Limiting Toxicity
Using NCI CTCAE 4.0
Time frame: Assessed at Day 8 and 15 after randomization
Ki67
Relative change from baseline to surgery in Ki67 IHC expression ("relative" antripoliferative responders)
Time frame: Assessed at Day15 after randomization
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