Status:
COMPLETED
ZoNantax - Zolendronic Acid as Neoadjuvant Therapy Plus Anthracycline and Taxane in Locally Advanced Breast Cancer
Lead Sponsor:
Susanne Crocamo
Conditions:
Breast Cancer
Breast Disease
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01472146
Start Date
October 1 2011
End Date
May 1 2017
Last Update
May 9 2017
Active Locations (1)
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1
Hospital do Cancer III - INCA
Rio de Janeiro, Brazil, 20560-120