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
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 2
Healthy volunteers: no

Brief 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.

Arms:
arm 1: 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.

Interventions: intervention 1: anastrozole intervention 2: pazopanib hydrochloride intervention 3: therapeutic conventional surgery
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Undergo definitive surgery

Protocol document: