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

NCT01472146 | Completed Phase 2 DMC

• 1 other identifier: Zo-neo2011
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Breast Disease; Neoplasms; Neoplasms by Site

Keywords

Neoadjuvant therapy; Breast cancer HER2 positive; zolendronic acid

Outcome Measures

Primary Outcomes (1)

• Evaluate the residual cancer burden (RCB)

  Use MD Anderson calculator to quantify the minimal residual disease

  6 months

Secondary Outcomes (3)

• Assessing the tolerance to standard neoadjuvant treatment plus zolendronic acid,according to the common toxicity criteria Terminology Criteria for Adverse Events version 3.0.

  6 months

• Assessment of the difference in gene expression according to treatment response

  6 months

• Prediction of pathological response by MRI calculated from the sequence of apparent diffusion coefficient (ADC)

  4 months

Study Arms (1)

Zometa neoadjuvant HER2 breast cancer

EXPERIMENTAL

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: Zo-Nantax

Interventions

Zo-Nantax DRUG

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

Also known as: Other Names:, Adriblastine RD, Cytoxan, Taxotere®, Herceptin®, Zometa

Zometa neoadjuvant HER2 breast cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage IIA to IIIB HER-2 positive breast cancer
• ECOG performance ≤ 2
• Adequate hematologic function with:
• Absolute neutrophil count (ANC)\> 1500/mm³
• Platelets ≥ 100.000/mm³
• hemoglobin ≥ 9g/dL
• 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
• Adequate cardiac function
• Left ventricular ejection fraction (LVEF)with institutional normal range
• Knowledge of the investigational nature of the study and ability to provide consent for study participation

You may not qualify if:

• Previous diagnostic of breast or other cancer
• Pregnancy
• Metastatic breast cancer
• Bilateral, synchronous breast cancer
• 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
• Neuropathy grade \> 2 by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)

Sponsors & Collaborators

• Susanne Crocamo: lead

Study Sites (1)

Hospital do Cancer III - INCA

Rio de Janeiro, 20560-120, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Diseases; Neoplasms; Neoplasms by Site

Interventions

Cyclophosphamide; Docetaxel; Trastuzumab; Zoledronic Acid

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Diphosphonates; Organophosphonates; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Susanne C Costa, MD

  Hospital do Cancer III - INCA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Oncologist

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: November 16, 2011
• Study Start: October 1, 2011
• Primary Completion: July 1, 2016
• Study Completion: May 1, 2017
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)