Neo-adjuvant Therapy With Anastrozole Plus Pazopanib in Stage II and III ER+ Breast Cancer
|Estrogen Receptor-positive Breast Cancer Human Epidermal Growth Factor 2 Negative Carcinoma of Breast Male Breast Cancer Recurrent Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer||Drug: anastrozole Drug: pazopanib hydrochloride Procedure: therapeutic conventional surgery||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Neo-adjuvant Therapy With Anastrozole Plus Pazopanib in Stage II and III ER+ Breast Cancer|
- Rate of pCR at primary site (T0) and nodal sites (T0N0) [ Time Frame: Six months from the initiation of neoadjuvant therapy ]Defined as no evidence of microscopic invasive tumor present. Determined by pathology. Estimated with an exact 95% confidence interval.
- Proportion of patients achieving sustained decrease in ki-67 [ Time Frame: 12 weeks from the initiation of neoadjuvant therapy ]
- Proportion of patients achieving down-staging to a pathologic stage 0 or 1 [ Time Frame: Six months from the initiation of neoadjuvant therapy ]
|Actual Study Start Date:||July 13, 2011|
|Study Completion Date:||April 12, 2012|
|Primary Completion Date:||April 12, 2012 (Final data collection date for primary outcome measure)|
Experimental: Neoadjuvant enzyme inhibitor therapy
Patients receive pazopanib hydrochloride* PO QD and anastrozole PO QD for 6 months in the absence of disease progression or unacceptable toxicity. Patients then undergo therapeutic conventional surgery.
NOTE: *Pazopanib hydrochloride is stopped 7-14 days before definitive surgery.
Other Names:Drug: pazopanib hydrochloride
Other Names:Procedure: therapeutic conventional surgery
Undergo definitive surgery
I. To determine the pathologic complete response (pCR) rate at surgery.
I. To evaluate alternative measurements of anti-tumor activity: proportion of patients achieving sustained decrease in antigen KI-67 (ki-67) at 12 weeks of therapy with anastrozole plus pazopanib (pazopanib hydrochloride); proportion of patients achieving down-staging to a pathologic stage 0 or 1 at surgery.
II. To assess qualitative and quantitative toxicity of this combination, with special emphasis on the frequency of events grade 3 or greater, or the occurrence of unexpected toxicities.
Patients receive pazopanib hydrochloride* orally (PO) once daily (QD) and anastrozole PO QD for 6 months in the absence of disease progression or unacceptable toxicity. Patients then undergo definitive surgery.
NOTE: *Pazopanib hydrochloride is stopped 7-14 days before surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394211
|United States, Arizona|
|Arizona Cancer Center|
|Tucson, Arizona, United States, 85724-5024|
|Principal Investigator:||Robert Livingston||University of Arizona|