Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent
Female patients (age ≥18 years)
HER2-negative metastatic breast cancer (stage IV)
Patients will be receiving chemotherapy or hormonal therapy
Patients with no bone metastasis and ≤1 prior treatments for metastatic breast cancer. Patients with newly diagnosed metastatic breast cancer may have received adjuvant or neoadjuvant chemotherapy as long as treatment was completed ≥12 months prior to relapse.
Asymptomatic brain metastasis is permitted if all of the following criteria are met:
1. no sign of clinical progression or known progression of brain metastasis
2. off steroids for at least 2 weeks prior to study enrollment
Stable renal function: two serum creatinine determinations of \<3 mg/dL, obtained no less than 7 days apart (one value may be obtained within 6 weeks prior to Screening; the second must be obtained during Screening)
ECOG performance status of 0 or 1
Life expectancy of ≥ 6 months
Negative serum pregnancy test
Ability and willingness to comply with all study requirements
You may not be if
Known hypersensitivity to zoledronic acid or other bisphosphonates
Patients with history of another malignancy within the last two years prior to study enrollment, except cured basal cell carcinoma of the skin or excised carcinoma in site of the cervix
Use of concurrent investigational agents is prohibited. Prior use of investigational agents is permitted if discontinued ≥30 days prior to Screening.
No prior therapy with an antiresorptive agent
Patients with active brain metastases or meningeal metastases
Current or recent (in the six months prior to initial study drug treatment) severe cardiovascular disease (defined as uncontrolled congestive heart failure), hypertension refractory to treatment, or poorly controlled Type I/II diabetes mellitus
Current active dental problems including dental abscess or infection of the jawbone (maxilla or mandible) or a current or prior diagnosis of osteonecrosis of the jaw
Patients who have received radiotherapy ≤ 4 weeks prior to study enrollment or who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions ≤ 2 weeks prior to study enrollment is allowed
Patients who have undergone major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) ≤ 4 weeks prior to study enrollment or who have not recovered from side effects of such therapy
Corrected (i.e., adjusted for serum albumin) serum calcium of \<8.0 mg/dL (2.00 mmol/L) or ≥ 12 mg/dL (3.00 mmol/L)
Pregnant or breast-feeding females
Women of child-bearing potential who are not willing/able to use effective methods of birth control (e.g., abstinence, oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide)
History of non-compliance to medical regimens and/or patients who are considered unreliable
