E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic bone disease due to breast cancer |
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MedDRA Classification |
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 |
There is evidence to suggest that suppression in markers of bone resorption may correlate with a reduction in skeletal related events and metastatic bone pain. Bone markers therefore act as useful determinants for assessing clinical responses to bisphosphonate therapy, which reduces bone resorption.
The primary objective is to evaluate the serum levels of biochemical markers of bone turnover in patients with breast cancer and malignant bone disease switched from i.v. Zoledronic acid to oral Ibandronate.
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E.2.2 | Secondary objectives of the trial |
Safety parameters:Serum creatinine, calculated creatinine clerarance |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
-Signed informed consent -Female patients >18 years of age with histologically confirmed breast cancer with at least one osteolytic or mixed bone lesion confirmed by X-ray, CT scan or MRI (confirmation within 6 months before screening) -WHO performance status 0, 1 or 2 at screening -Life expectancy > 6 months -Patients must had at least 2 cycles of Zoledronic acid therapy before sreeening -the last dose of Zoledronic acid has to be given >3 weeks prior to start of Ibandronate therapy -Adequate hematology, hepatic and renal function ( < 3.0mg/dL or < 266µmol/L) -Stable antineoplastic therapy (including corticosteroids) for a least 4 weeks prior to screening
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E.4 | Principal exclusion criteria |
- History of brain metastases - Bone surgery within 5 weeks of sreening - High dose chemotherapy (>3x normal intensity) within 6 months - Uncontrolled calcemia (albumin corrected > 2.7mmol/L and < 2.0mmol/L) - Paget’s disease, untreated esophagitis or gastric ulcers - Known hypersensitivity to Ibandronate - Women lactating, pregnant, of childbearing potential or less than one year after menopause (unless surgically sterile) not using a reliable contraceptive method: intrauterine device, mechanical contraception (condom, diaphragm), oral, injectable or implanted contraceptives or total abstinence. Women of childbearing potential must have a negative pregnancy test at screening
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective is to evaluate the serum levels of biochemical markers of bone turnover in patients with breast cancer and malignant bone disease switched from i.v. Zoledronic acid to oral Ibandronate.
The change in bone resorption through Ibandronate will be described based on the monitoring of clinical laboratory results of the biochemical markers of bone turnover. The main efficacy endpoint is the stabilization of serum levels of the bone resorption marker s-CTX (cross linked C terminal telopeptide of type I collagen) 3 months after switching to the oral Ibandronate treatment regimen (50mg Ibandronate / day)
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
ZOLEDRONIC ACID is used as baseline |
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E.8.3 |
The trial involves single site in the Member State concerned
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E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | Information not present in EudraCT |
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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The investigator has the right to terminate the study at any time. In terminating the study the investigator will assure that adequate consideration is given to the protection of the patients interests. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |