A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Metastatic Bone Disease.

Roche

Status and phase: Withdrawn; Phase 2

Conditions: Bone Neoplasm; Neoplasm Metastasis; Pain

Treatments: Drug: ibandronate [Bondronat]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00478270

ML20247

Details and patient eligibility

About

This single arm study will assess the efficacy of loading doses of intravenous Bondronat in reducing pain in patients with breast cancer and metastatic bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• breast cancer;
• bone metastases;
• mean worst pain score >=4 during 3 day baseline period;
• stable dose of analgesics over a 3 day baseline period;
• adequate renal function.

Exclusion criteria

• bisphosphonate treatment within 3 weeks of study enrollment;
• a change in antineoplastic treatment within 6 weeks of study enrollment;
• bone radiation within 2 weeks of study enrollment;
• active infection.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

1

Experimental group

Treatment:

Drug: ibandronate [Bondronat]