Randomized Phase II Study to Assess PD 0332991 in Breast Cancer — POP  

Untreated Operable Early Breast Cancer Clinical Trial

Official title: Randomized Short-term Pre-surgical Study to Assess the Effects of PD 0332991 in Early Breast Cancer Patients

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Untreated Operable Early Breast Cancer

• NCT number: NCT02008734
• Study type: Interventional
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Status: Completed
• Phase: Phase 2
• Start date: January 2014
• Completion date: January 2016