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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients

NCT00381368

Breast Cancer

UNKNOWN PHASE2

Ibandronate or Zoledronate in Treating Patients With Newly Diagnosed Bone Metastases From Breast Cancer

NCT00326820

Breast Cancer Hypercalcemia of Malignancy Metastatic Cancer

UNKNOWN PHASE3

clinIcal Efficacy and Safety of Incadronate in Breast Cancer With Bone Metastases

NCT06392217

Breast Cancer Bone Metastases

RECRUITING

Pamidronate Administration in Breast Cancer Patients With Bone Metastases

NCT00128297

Breast Cancer Neoplasm Metastasis

COMPLETED PHASE4

Metabolomics Explores Biomarkers for Metastatic Breast Cancer

NCT04302415

Breast Cancer

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Bone Neoplasm Neoplasm Metastasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

ibandronate [Bondronat]

Intervention Type DRUG

6mg iv on days 1-3

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ibandronate [Bondronat]

6mg iv on days 1-3

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No