Clinical trial NCT00512993 (phase 3, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: zoledronic acid
SMILES: OC(CN1C=CN=C1)(P(O)(O)=O)P(O)(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained and documented according to the local
             regulatory requirements prior to beginning specific protocol procedures;

          -  Complete baseline documentation sent to GBG;

          -  Prior preoperative chemotherapy for at least 4 cycles, of which at least two must
             contain a taxane and an anthracycline;

          -  Completely resected unilateral or bilateral primary carcinoma of the breast with
             histologically detectable tumor residuals (ypT1-4) and/or histology confirmed
             involvement of axillary nodes (ypN1-3). Sentinel node biopsy is allowed, but complete
             axillary clearance is mandatory in node positive cases;

          -  A maximum interval of 3 years from date of axillary surgery to entering this trial;

          -  Age 18 years or older;

          -  Karnofsky index >= 70%;

          -  Life expectancy of at least 10 years, disregarding the diagnosis of cancer;

          -  No clinical evidence of local recurrence or distant metastases. Complete staging
             work-up: All patients must have breast ultrasound, chest X-ray, ultrasound or CT scan
             of the liver within 3 months prior to registration, as well as (bilateral) mammography
             or breast MRI and bone scan within 8 months prior to registration. In case of a
             positive bone scan, bone X-ray is mandatory. Other tests may be performed as
             clinically indicated;

          -  Adequate renal and hepatic function (serum creatinine, bilirubin, and transaminases
             within 1.5 × upper normal range);

          -  Patients must be available and compliant for treatment and follow-up. Patients
             registered on this trial must be treated and followed up at the participating center.

        Exclusion Criteria:

          -  Known hypersensitivity reaction to the investigational compound;

          -  Prior postoperative chemotherapy;

          -  Prior treatment with bisphosphonates since breast cancer surgery;

          -  Pregnant or lactating patients. Patients of childbearing potential must have a
             negative pregnancy test (urine or serum) within 14 days prior to registration and must
             implement adequate non-hormonal contraceptive measures (barrier methods, intra uterine
             contraceptive devices, sterilization) during study treatment;

          -  History of diseases with influence on bone metabolism, such as Paget's disease of bone
             and primary hyperparathyroidism or osteoporosis requiring treatment at the time of
             study entry or considered likely to become necessary within the six months

          -  Other serious illness or medical condition that may interfere with the understanding
             and giving of informed consent and the conduct of the study

          -  Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or
             carcinoma in situ of the uterine cervix)

          -  Concurrent treatment with other experimental drugs or any other anti-cancer therapy;

          -  Abnormal renal function as evidenced by a calculated creatinine clearance < 30
             ml/minute;

          -  Serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or > 12.0 mg/dl (3.00 mmol/L)

          -  Concurrent treatment with sex hormones. Prior treatment must be stopped before study
             entry;

          -  Current active dental problems including infection of the teeth or jawbone (maxilla or
             mandibular); dental or fixture trauma, or a current or prior diagnosis of
             osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after
             dental procedures.

          -  Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)

          -  Male patients.