Pazopanib Hydrochloride and Anastrozole Before Surgery in Treating Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer
This phase II trial studies how well giving pazopanib hydrochloride and anastrozole before surgery works in treating patients with stage II-III estrogen receptor-positive breast cancer. Pazopanib hydrochloride and anastrozole may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pazopanib hydrochloride and anastrozole together before surgery may make the tumor smaller and reduce the amount of normal cells that have to be removed
Estrogen Receptor-positive Breast Cancer
HER2-negative Breast Cancer
Male Breast Cancer
Recurrent Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Drug: pazopanib hydrochloride
Procedure: therapeutic conventional surgery
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 2 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Proportion of patients achieving down-staging to a pathologic stage 0 or 1 [ Time Frame: Six months from the initiation of neoadjuvant therapy ] [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Treatment (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 definitive 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.
|United States, Arizona|
|Arizona Cancer Center|
|Tucson, Arizona, United States, 85724-5024|
|Principal Investigator:||Robert Livingston||University of Arizona|