E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with Breast Cancer and Skeletal Metastases Experiencing Moderate to Severe Pain |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049038 |
E.1.2 | Term | Metastatic bone pain |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to establish the pain response of the treatment with ibandronic acid in patients with Breast cancer and painful metastatic bone disease. In this study, pain response is defined as a: ≥ 25% decrease in mean pain score on days 5 to 7 compared to mean pain score at baseline as determined by the “WORST PAIN” scale of the Brief Pain Inventory (BPI), with no more than a 35% increase in mean analgesic consumption in the observation phase compared to mean baseline analgesic consumption.
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E.2.2 | Secondary objectives of the trial |
The secondary endpoints will consist of • Pain response as defined above determined by the “AVERAGE PAIN” scale of the BPI • Time to pain response based on the WORST PAIN scale of the BPI • Analgesic consumption expressed as opioid equivalents • WHO Performance Score • Interference Scales of the BPI • Patient Global Assessment
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Histological or cytological evidence of breast cancer • Presence of bone metastases documented on bone x-ray, bone scintigram, CT scan or MRI scan • Pain score of > 4 on the WORST PAIN scale of BPI. • Bone pain must correspond to areas of metastases on bone x-ray, bone scintigram, CT scan or MRI scan; • Age > 18 years • WHO Performance Score of 0 – 3 • Adequate renal function as evidenced by a calculated creatinine clearance > 50 mL/min by Cockcroft-Gault method. • Normal serum calcium level • Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial. • By clinical judgement of investigator, the prescribed analgesic therapy of the patient is stable, and, as foreseen at inclusion, it will not require modification during the 7 days of the trial.
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E.4 | Principal exclusion criteria |
• Patients with an active infection or with a fever > 38.50 C within 3 days of the first scheduled day of dosing • Patients with an impending pathological fracture (erosion of at least 1/3 of the cortex by neoplastic process) • Patients with known untreated CNS or meningeal metastases • Patients who have received a bisphosphonate within 3 weeks of the start of the trial; however, use of bisphosphonates prior to this period IS PERMITTED • Patients with known hypersensitivity to any of the components of ibandronic acid • Radiotherapy to bone within 4 weeks of enrolment • Patients with Paget’s disease of bone • Patients who are pregnant or lactating • Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or to interfere with the interpretation of the results. • Patient who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of dosing: investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication. “Investigational therapy” does not refer to approved agents used in a clinical trial in an off-label manner, e.g., in a different dose or schedule, or in a non-approved tumor.
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E.5 End points |
E.5.1 | Primary end point(s) |
The main efficacy endpoint is bone pain response. In this study, pain response is defined as a: ≥ 25% decrease in mean pain score on days 5 to 7 compared to mean pain score at baseline as determined by the “WORST PAIN” scale of the Brief Pain Inventory (BPI), with no more than a 35% increase in mean analgesic consumption on days 5 to 7 compared to mean baseline analgesic consumption.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 15 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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adverse events occurring up to 28 days following the last administration of study drug and the pain status on Days 14 and 28 should be reported on the CRF and followed. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |