ZoNantax - Zolendronic Acid as Neoadjuvant Therapy Plus Anthracycline and Taxane in Locally Advanced Breast Cancer
|ClinicalTrials.gov Identifier: NCT01472146|
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : May 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Breast Disease Neoplasms Neoplasms by Site||Drug: Zo-Nantax||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Clinical Trial of Neoadjuvant Treatment With Zolendronic Acid Plus Anthracycline and Taxane in Locally Advanced Breast Cancer|
|Actual Study Start Date :||October 2011|
|Primary Completion Date :||July 2016|
|Study Completion Date :||May 2017|
Experimental: Zometa neoadjuvant HER2 breast cancer
Zo-Nantax arm - Neoadjuvant chemotherapy with association of zoledronic acid and standard treatment with anthracycline followed taxane plus trastuzumab in locally advanced breast cancer HER2 positive HR positive/negative.
Drug:Cyclophosphamide Drug:Adriamycin Drug:Docetaxel Drug:Trastuzumab Drug:Zolendronic acid
Drug: AC Adriamycin 60mg/m2 IV plus cyclophosphamide 600mg/m2 every 21 days for 4 cycles
Docetaxel 100 mg/m2 every 21 days for 4 cycles.
Trastuzumab 8mg/kg [loading dose] once then 6mg/kg IV every 21 days for 3 cycles plus docetaxel.
Drug: zolendronic acid
Zolendronic acid 4mg IV every 21 days for 8 cycles combine with chemotherapy
- Evaluate the residual cancer burden (RCB) [ Time Frame: 6 months ]Use MD Anderson calculator to quantify the minimal residual disease
- Assessing the tolerance to standard neoadjuvant treatment plus zolendronic acid,according to the common toxicity criteria Terminology Criteria for Adverse Events version 3.0. [ Time Frame: 6 months ]CTC 4.0
- Assessment of the difference in gene expression according to treatment response [ Time Frame: 6 months ]Through microarray assays
- Prediction of pathological response by MRI calculated from the sequence of apparent diffusion coefficient (ADC) [ Time Frame: 4 months ]Make MRI before the start of chemotherapy, after the second cycle and before surgery, and evaluate the changes in the diffusion of water
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01472146
|Hospital do Cancer III - INCA|
|Rio de Janeiro, Brazil, 20560-120|
|Principal Investigator:||Susanne C Costa, MD||Hospital do Cancer III - INCA|