Clinical trial NCT02347163 (phase 2, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: zoledronate
SMILES: OC(CN1C=CN=C1)(P(O)(O)=O)P(O)(O)=O
Reason stopped: 
    the study stopped prematurely due to the low accrual rate
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of non-metastatic operable primary invasive TN
             breast cancer subjected to diagnostic core biopsy

          -  TNBC defined as HER2/ER/PgR negative receptors

          -  Ki67 and p53 expression determined by IHC

          -  Tumour tissue availability at time of diagnosis for IHC evaluation of p53/PIN1,
             YAP/TAZ and Ki67 protein expression and for RT-PCR molecular testing of critical
             genes: p53/PIN1, YAP/TAZ

          -  Age ≥ 18 years old

          -  ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1

          -  Patients with reproductive potential. Female patients must have a negative serum
             pregnancy test within 7 days prior to start of trial. Patients must agree to use a
             medically acceptable method of contraception throughout the treatment period and for 3
             months (female patients) and 6 months (male patients) after discontinuation of
             treatment

          -  Written informed consent signed prior to enrolment according to ICH/GCP.

        Exclusion Criteria:

          -  Presence of metastatic disease

          -  Clinical indication of debulking neo-adjuvant treatment

          -  Previous investigational treatment for any condition within 4 weeks from study
             registration

          -  Treatment with bisphosphonates, denosumab or other drug that, in the Investigator's
             judgment, affects bone metabolism

          -  Treatment with statins or other drugs that, in the Investigator's judgment,
             potentially affect the mevalonate pathway

          -  Any previous treatment for the currently diagnosed breast cancer, including radiation
             therapy, chemotherapy, biotherapy and/or hormonal therapy

          -  Inadequate bone marrow, hepatic or renal function including the following

               1. Hb< 9.0 g/dL, absolute neutrophil count < 1.5 x 109/L, platelets <100 x 109/L

               2. Total bilirubin > 1.5 x ULN, excluding cases where elevated bilirubin can be
                  attributed to Gilberts Syndrome

               3. AST (SGOT), ALT (SGPT) > 2.5 x ULN Creatinine > 1.2 x ULN, calcium <8.6mg/dL

          -  Co-existing active infection or serious concurrent illness that, at the judgment of
             the investigator, contra-indicate the inclusion of the patient in the study

          -  Co-existing dental diseases that form a contraindication to the use of zol or need for
             immediate dental work

          -  Any medical or other condition that in the investigator's opinion renders the patient
             unsuitable for this study due to unacceptable risk

          -  Psychiatric disorders or altered mental status precluding understanding of the
             informed consent process and/or completion of the necessary study assessment and
             procedures

          -  Anticipation of need for major surgical procedure during the course of the trial

          -  Known hypersensitivity to any excipients of zoledronate

          -  Pregnant or breast feeding women.