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Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 25, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT01723774). This is a study registration, not published results. Lead sponsor: Washington University School of Medicine. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 84 participants (ACTUAL). Conditions: Breast Neoplasms. Interventions: DRUG: PD0332991; DRUG: Anastrozole; DRUG: Goserelin; PROCEDURE: Surgery (standard of care); PROCEDURE: Tumor biopsy. Primary outcome measures: Number of Participants With Complete Cell Cycle Arrest at Cycle 1 Day 15 (PIK3CA Wild Type Cohort Only) , At cycle 1 day 15 (2 weeks); Number of Participants With Complete Cell Cycle Arrest at Cycle 1 Day 15 (Endocrine Resistant Cohort Only) , At cycle 1 day 15 (2 weeks). 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.