Breast Cancer Clinical Trial
Official title:
Phase II Clinical Trial of Neoadjuvant Treatment With Zolendronic Acid Plus Anthracycline and Taxane in Locally Advanced Breast Cancer
The purpose of this study is to evaluate the association of zoledronic acid with standard treatment with anthracycline followed taxane plus trastuzumab in locally advanced breast cancer HER 2 positive.
This trial combines zolendronic acid with anthracycline followed taxane plus trastuzumab for
neoadjuvant treatment of HER 2 positive stage II/III breast cancer.
Zoledronic acid (ZOL) has activity of anti-bone resorption and shows diverse anti-tumor
effects in vitro. Some chemical and biological characteristics of ZOL indicate potential for
inhibition of tumor growth in pre clinical studies
The primary objective of the study is to evaluate the residual cancer burden (RCB) with the
addition of zolendronic acid to standard neoadjuvant therapy. RCB is calculated as a
continuous index combining pathologic measurements of primary tumor (size and cellularity)
and nodal metastases (number and size). RCB index is a significant predictor of distant
relapse-free survival, and can be used to define categories of near-complete response and
chemotherapy resistance after neoadjuvant chemotherapy compared with currently used risk
factors. Additionally, the study will collect tissue biopsies and blood before and after
treatment in order to correlate clinical outcomes with gene expression and radiologic data
to predictive response.
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