Clinical Trial Result Information

Title of Study:
Infusion of 4mg or 6mg Ibandronate in patients with breast cancer and bone metastases

Fast Facts:

Protocol number:	ML16415
Sponsor:	Hoffmann-La Roche AG
Company division:	Pharmaceutical
Product name:	Bondronat
Generic name:	Ibandronate
Phase of development:	III
Therapeutic area, approved indication:	Pain; Bone Neoplasms; Neoplasm Metastasis
Date of report:	10/1/2004

Clinical study summary:
This trial was prematurely terminated by the investigator, due to the regulatory approval of the 6mg Bondronat dose. Clinical trial results, other than key safety statements, have not been posted, due to insufficient data.

Study center(s) :
25 centers in Germany

Objectives:
To compare the efficacy of 4mg and 6mg Bondronat.

Methodology:
Patients were randomized to receive either 4mg or 6mg Bondronat infusions once a month

Diagnosis and main criteria for inclusion:
Histologically confirmed breast cancer and bone metastases; age ≥ 18 years.

Test product, dose and mode of administration or test procedure:
Bondronat (ibandronate) 4mg or 6mg monthly; infusion time 30 minutes

Duration of treatment:
24 months (planned)

Criteria for evaluation (efficacy, safety):
Primary efficacy parameter: proportion of patients with at least one skeletal related event. Safety parameters: serious adverse events, adverse events related to study medication. Adverse event of special interest: increase of serum creatinine by ≥ 1mg/dL

Statistical methods:
Because of the premature termination of the study, there was no evaluation of the primary efficacy parameter. Safety data were evaluated descriptively.

Summary (efficacy, safety, other results):
Safety: There were 6 deaths (5 in the 4mg group and 1 in the 6mg group), but no deaths were considered to be related to Bondronat treatment. A total of 25 patients had serious adverse events, but none was considered to be related to Bondronat treatment.

Conclusions:
No conclusions can be drawn from this study, due to its early termination