Neo-adjuvant Therapy With Anastrozole Plus Pazopanib in Stage II and III ER+ Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01394211|
Recruitment Status : Terminated (Slow accrual)
First Posted : July 14, 2011
Results First Posted : July 25, 2018
Last Update Posted : July 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neo-adjuvant Therapy With Anastrozole Plus Pazopanib in Stage II and III ER+ Breast Cancer|
|Actual Study Start Date :||July 13, 2011|
|Actual Primary Completion Date :||April 12, 2012|
|Actual Study Completion Date :||April 12, 2012|
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.
Drug: pazopanib hydrochloride
Procedure: therapeutic conventional surgery
Undergo definitive surgery
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394211
|United States, Arizona|
|Arizona Cancer Center|
|Tucson, Arizona, United States, 85724-5024|
|Principal Investigator:||Robert Livingston||University of Arizona|