Clinical trial · Interventional
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
NCT01472146CI-TRIAL-00027465completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Disease | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasms by Site | Neoplasm by Site | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zo-Nantax | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zometa neoadjuvant HER2 breast cancer
- description
- 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
- interventionNames
- Drug: Zo-Nantax
Primary outcomes (1)
- measure
- Evaluate the residual cancer burden (RCB)
- timeFrame
- 6 months
- description
- Use MD Anderson calculator to quantify the minimal residual disease
Secondary outcomes (3)
- measure
- Assessing the tolerance to standard neoadjuvant treatment plus zolendronic acid,according to the common toxicity criteria Terminology Criteria for Adverse Events version 3.0.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.