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

Condition(s) targeted: Breast Cancer

Intervention: Ibandronic acid (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Turku

Official(s) and/or principal investigator(s):
Outi Paija, MD, PhD, Principal Investigator, Affiliation: Dept of Oncology, Turku University Hospital, Finland

Overall contact:
Outi Paija, MD, PhD, Phone: +358-2-3130000, Ext: 52863, Email: outi.paija@tyks.fi

The purpose of the study is to determine the efficacy and safety of a three time repeated loading dose of intravenous ibandronate (ibandronic acid), 6 mg, in breast cancer patients with painful skeletal metastases.

Official title: 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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

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

Analgesic consumption during the same period will additionally be assessed

Secondary outcome:

Bone markers: serum 1CTP, serum P1NP, serum NTX on day 1 before dosing, and on days 7 and 28

World Health Organization (WHO) performance status

Safety: serum cystatin C and serum creatinine, and reporting of adverse events

Detailed description: 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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Outi Paija, MD, PhD, Phone: +358-2-3130000, Ext: 52863, Email: outi.paija@tyks.fi

Dept of Oncology, Tampere University Hospital, Tampere 33521, Finland; Not yet recruiting
Pirkko Kellokumpu-Lehtinen, PhD, professor, Principal Investigator

Dept of Oncology, Helsinki University Central Hospital, Helsinki 00029, Finland; Not yet recruiting
Tiina Saarto, MD, PhD, Principal Investigator

Dept of Oncology, Oulu University Hospital, Oulu 90029, Finland; Recruiting
Arja Jukkola, MD, PhD, Principal Investigator

Starting date: October 2006
Last updated: December 1, 2006