E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Menopausal women on treatment for BC, with higher risk of recurrence due to augmented level of T |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006187 |
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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 |
Relatively high level of Testosterone, due to insulin resistance, are asociated with higher risk of breast cancer (BC) and even of recurrences of BC. The main objective is to define the smallest dose of Metformin able to reduce augmented serum level of T and to modify other metabolic parameters in menopausal women on treatment for BC (randomised comparison of two doses) |
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E.2.2 | Secondary objectives of the trial |
To define the toleralibity of Metformin 1000 - 1500 mg/d in menopausal women on treatment for BC |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Women with previous surgery for BC, in spontaneous menopause, aged less than 70 years, with serum T level above the median, in one of the following conditions (characterized by endocrine and metabolic stabilization): 1) At least 6 months from surgery in absence of systemic treatment; 2) In therapy with Tamoxifen since at least 6 months with the perspective of prosecute it for at least another year; 3) At least 6 months from the end of chemiotherapy. |
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E.4 | Principal exclusion criteria |
Previous cardiovascular disease (myocardial infarction, coronary disease, stroke); diabetes ID and NID; use of statins; cotraindications to the use of Metformin, in particular the conditions at risk of lactic acidosis. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To define the smallest dose of Metformin able to reduce augmented serum level of Testosterone in women on treatment for breast cancer |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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 | No |
E.8.2.3.1 | Comparator description |
- same IMP used at different dosage |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
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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ULTIMO PRELIEVO DI SANGUE DELL`ULTIMO SOGGETTO INSERITO NELLO STUDIO |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |