A 24-Week Blinded Study Conducted at Multiple Centers, Evaluating the Safety and Effectiveness of Various Doses of the Investigational Drug (CAL) Versus Zoledronic Acid (Zometa®) When Randomly Assigned to Patients With Breast Cancer That Has Metastasized to Bone

Inclusion Criteria

Major Inclusion Criteria – Others Stipulated within the Protocol

The study physician must assure you have/are:

- Must be a female at least 18 years of age and be using an effective form of birth
control.

- A documented history of breast cancer and at least one bone metastasis that has not
been previously treated by radiation or surgery, and is not anticipated to be treated
within the next 24 weeks.

- A total body bone scan and other radiographic scan(s) performed on you within 4 weeks
prior to or during the screening period sufficient to image all sites of bone
metastases.

- You must be willing to perform a daily telephone diary and be willing to keep a paper
diary and provide voluntary consent to participate in this study.

Major Exclusion Criteria – Others Stipulated within the Protocol

The study physician must assure you do not have/are not:

- A change in analgesic (pain relief) type medication during the screening period
(example, non-narcotic to narcotic).

- Received radiation therapy to any bone metastasis or started a new course of
chemotherapy within 3 weeks prior to the screening visit or during the screening
period.

- Used any bisphosphonate type drug during the 30 days prior to the anticipated first
dose of study drug

- Vertebral spine or weight-bearing bone metastasis that would place you at imminent
risk for fracture or surgical intervention.

- Evidence of active infection or immune deficiency, renal failure, abnormal liver
function, or a serum calcium level > 10.1 mg/dL.

- Use of any investigational drug within 30 days prior to screening.