Clinical Trial: NCT01723774
PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 2| Lead Sponsor: | Washington University School of Medicine |
| Information Provided By: | Washington University School of Medicine |
| Last Update Posted: | 2026-09-25 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: PD0332991
- Drug: Anastrozole
- Drug: Goserelin
- Procedure: Surgery (standard of care)
- Procedure: Tumor biopsy
Other Study ID Numbers
- 201301106
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Estimated)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Washington University School of Medicine |
| Information Provided By: | Washington University School of Medicine |
| Last Update Posted: | 2026-09-25 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: PD0332991
- Drug: Anastrozole
- Drug: Goserelin
- Procedure: Surgery (standard of care)
- Procedure: Tumor biopsy
Other Study ID Numbers
- 201301106