NCT01394211

Neo-adjuvant Therapy With Anastrozole Plus Pazopanib in Stage II and III ER+ Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

OBJECTIVES: I. To determine the pathologic complete response (pCR) rate at surgery. SECONDARY OBJECTIVES: 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. OUTLINE: 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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	anastrozole	Given PO
DRUG	pazopanib hydrochloride	Given PO
PROCEDURE	therapeutic conventional surgery	Undergo definitive surgery

Timeline

• Start date: 2011-07-13
• Primary completion: 2012-04-12
• Completion: 2012-04-12
• First posted: 2011-07-14
• Last updated: 2018-07-26
• Results posted: 2018-07-26

Locations

1 site across 1 country: United States