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

Plain-language summary

This study evaluated adding zoledronic acid to anthracycline and taxane drugs as pre-surgery (neoadjuvant) treatment in patients with locally advanced breast cancer. It enrolled patients with stage IIA-IIIB, HER-2 positive breast cancer. It was carried out in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Susanne Crocamo

Intervention

Zo-Nantax

Start date

10/1/2011

Estimated completion

5/1/2017

Countries

Brazil

Related genes

Locations

• Rio de Janeiro, Brazil

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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)