An Open-Label, Randomised Phase 1b/2 Study Of PF-04691502 In Combination With Letrozole Compared With Letrozole Alone In Patients With Estrogen Receptor Positive, Her-2 Negative Early Breast Cancer

PF-04691502

PF-04691502 in combination with Letrozole

Letrozole

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Phase 1B

Change From Baseline in Ki-67 Percent Positive Tumor Cells in Biopsied Tumor Tissue at Week 6: Phase 2

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Phase 2

Number of Participants With Clinically Significant Laboratory Tests Abnormalities: Phase 1B and 2

Number of Participants With Clinically Significant Abnormalities in Vital Signs: Phase 1B and 2

Number of Participants With Clinically Significant Abnormalities in Corrected QT (QTc) Interval: Phase 1B

Number of Participants With Objective Response (OR): Phase 1B and 2

Pharmacokinetic (PK) Parameters of PF-04691502 and Letrozole: Phase 1B and 2

Change From Baseline in Pharmacodynamic, Cell Proliferation and Survival Biomarkers in Biopsied Tumor Tissue at Week 2 and 6: Phase 2

Number of Participants With Genetic Alterations: Phase 2