CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 84 enrolled
Drug / intervention
PD0332991 +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01723774
NCT01723774Phase 2Active

A Phase II Trial of Neoadjuvant PD 0332991, a Cyclin-Dependent Kinase (Cdk) 4/6 Inhibitor, in Combination With Anastrozole in Women With Clinical Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer

Washington University School of Medicine·interventional·Posted Nov 8, 2012·Updated Dec 9, 2025

In Brief

A Phase 2 clinical trial evaluating PD0332991, Anastrozole, and 3 other interventions for Breast Neoplasms. Active but no longer recruiting, targeting 84 participants across 4 sites.

Detailed Summary

A Phase II study to investigate the potential utility of PD 0332991 in the treatment of early stage ER+ Human epidermal growth factor receptor 2 (HER2)- breast cancer, to investigate whether the combination of PD 0332991 and anastrozole is able to: 1) improve the pathologic complete response rate when compared to the historical control of single agent aromatase inhibitors, 2) result in fewer patients with on therapy Ki67\>10% compared to historical control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 2Active
201320142015201620172018201920202021202220232024202520262027
First PostedNov 8, 2012
Enrollment StartApr 10, 2013
Primary CompletionApr 13, 2021
Study CompletionAug 24, 2026
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 13.7 years ago

Interventions

PD0332991drug

Anastrozoledrug

Goserelindrug

Surgery (standard of care)procedure

-Breast and axillary lymph node surgery

Tumor biopsyprocedure