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Phase II Open Label Study to Establish the Safety and Efficacy of Intravenous Loading Dose of Ibandronate 6 mg in 3 Consecutive Days in Breast Cancer Patients With Skeletal Metastases


Phase 2
N/A
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

Phase II Open Label Study to Establish the Safety and Efficacy of Intravenous Loading Dose of Ibandronate 6 mg in 3 Consecutive Days in Breast Cancer Patients With Skeletal Metastases


Painful skeletal metastases are a common site of advanced disease. For instance, in breast
cancer, and despite cancer treatments (radiotherapy, cytotoxic treatment and adequate
treatment of pain), the patients often need additional treatments that may relieve their
symptoms. Bisphosphonates, such as ibandronic acid, have in pilot studies shown a
significant decrease in pain scores, both after loading dose and after long-term treatment.
In this study the safety and efficacy of an intravenous loading dose of three times 6 mg
ibandronate during three consecutive days in breast cancer patients with painful skeletal
metastases will be studied.


Inclusion Criteria:



- Breast cancer with presence of bone metastases

- Pain score over 4 on the VAS

Exclusion Criteria:

- Patients with pathological fractures or medulla compression or neuropathic pain

- Patients with infection or corticosteroid treatment

- Pregnant or lactating patients

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Worst and average pain in movement and rest on the visual analogue scale (VAS) before the first dose, on days 2, 3, 7 and on day 28

Principal Investigator

Outi Paija, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept of Oncology, Turku University Hospital, Finland

Authority:

Finland: Finnish Medicines Agency

Study ID:

ML20115

NCT ID:

NCT00381368

Start Date:

October 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • breast cancer
  • skeletal metastases
  • bisphosphonate therapy
  • Breast cancer with painful skeletal metastases
  • Breast Neoplasms
  • Neoplasm Metastasis

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