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ZoNantax - Zolendronic Acid as Neoadjuvant Therapy Plus Anthracycline and Taxane in Locally Advanced Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Susanne Crocamo, Instituto Nacional de Cancer, Brazil
ClinicalTrials.gov Identifier:
NCT01472146
First received: September 20, 2011
Last updated: May 4, 2017
Last verified: May 2017
September 20, 2011
May 4, 2017
October 2011
July 2016   (Final data collection date for primary outcome measure)
Evaluate the residual cancer burden (RCB) [ Time Frame: 6 months ]
Use MD Anderson calculator to quantify the minimal residual disease
Evaluate the residual cancer burden (RCB) [ Time Frame: 6 months ]
Complete list of historical versions of study NCT01472146 on ClinicalTrials.gov Archive Site
  • 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
  • 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 ]
  • Assessment of the difference in gene expression according to treatment response [ Time Frame: 6 months ]
  • Prediction of pathological response by MRI calculated from the sequence of apparent diffusion coefficient (ADC) [ Time Frame: 4 months ]
Not Provided
Not Provided
 
ZoNantax - Zolendronic Acid as Neoadjuvant Therapy Plus Anthracycline and Taxane in Locally Advanced Breast Cancer
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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Cancer
  • Breast Disease
  • Neoplasms
  • Neoplasms by Site
Drug: Zo-Nantax

Experimental:

AC,Docetaxel,Trastuzumab,Zolendronate

Drug: AC Adriamycin 60mg/m2 IV plus cyclophosphamide 600mg/m2 every 21 days for 4 cycles

Drug: Docetaxel

Docetaxel 100 mg/m2 every 21 days for 4 cycles.

Drug: Trastuzumab

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

Other Names:
  • Other Names:
  • Adriblastine RD
  • Cytoxan
  • Taxotere®
  • Herceptin®
  • Zometa
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

Intervention: Drug: Zo-Nantax
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
May 2017
July 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Stage IIA to IIIB HER-2 positive breast cancer
  2. ECOG performance ≤ 2
  3. Adequate hematologic function with:

    • Absolute neutrophil count (ANC)> 1500/mm³
    • Platelets ≥ 100.000/mm³
    • hemoglobin ≥ 9g/dL
  4. Adequate hepatic and renal function with:

    • Serum bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ 2.5 x the institutional upper limit of normal (ULN)
    • Alkaline phosphatase )≤ 2.5 x the institutional upper limit of normal (ULN)
    • Serum creatinine ≤ 1.5 x the institutional upper limit of normal (ULN) or calculated creatinine clearance > 50 mL/min
  5. Adequate cardiac function

    • Left ventricular ejection fraction (LVEF)with institutional normal range
  6. Knowledge of the investigational nature of the study and ability to provide consent for study participation

Exclusion Criteria:

  1. Previous diagnostic of breast or other cancer
  2. Pregnancy
  3. Metastatic breast cancer
  4. Bilateral, synchronous breast cancer
  5. Any other disease(s), psychiatric condition, metabolic dysfunction, that contraindicates the use of study drugs or that woud make the patient inappropriate for this study
  6. Neuropathy grade > 2 by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
Sexes Eligible for Study: Female
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01472146
Zo-neo2011
Yes
Not Provided
Plan to Share IPD: No
Plan Description: I don`t plan to share IPD
Susanne Crocamo, Instituto Nacional de Cancer, Brazil
Susanne Crocamo
Not Provided
Principal Investigator: Susanne C Costa, MD Hospital do Cancer III - INCA
Instituto Nacional de Cancer, Brazil
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP