Phase II Clinical Trial of Neoadjuvant Treatment With Zolendronic Acid Plus Anthracycline and Taxane in Locally Advanced Breast Cancer
18 Years
75 Years
Female
Breast Cancer, Breast Disease, Neoplasms, Neoplasms by Site
Trial Information
Phase II Clinical Trial of Neoadjuvant Treatment With Zolendronic Acid Plus Anthracycline and Taxane in Locally Advanced Breast Cancer
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.
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)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Evaluate the residual cancer burden (RCB)
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Susanne C Costa, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hospital do Cancer III - INCA
Authority:
Brazil: Ministry of Health
Study ID:
Zo-neo2011
NCT ID:
NCT01472146
Start Date:
October 2011
Completion Date:
November 2014
Related Keywords:
- Breast Cancer
- Breast Disease
- Neoplasms
- Neoplasms by Site
- Neoadjuvant therapy
- Breast cancer HER2 positive
- zolendronic acid
- Breast Neoplasms
- Breast Diseases
- Neoplasms
- Neoplasms by Site
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