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

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Susanne Crocamo
• Treatments: Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin; Taxane; Trastuzumab

Criteria

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)