E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To determine whether there is evidence that carboplatin alone is an active and safe therapy in women with metastatic breast cancer who are BRCA1 or 2 mutation carriers.
Determinar si hay evidencia que la administración única de carboplatino es una terapia activa y segura en mujeres con cáncer de mama metastásico portadoras de la mutación BRCA1 o 2. |
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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 |
to determine whether there is evidence that carboplatin alone is an active and safe therapy in women with metatastic breast cancer who are BRCA 1&2 mutations carriers |
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E.2.2 | Secondary objectives of the trial |
to document whether treatment with carboplatin alone increases the time to diseases progression. To estimate progression free survival (PFS) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Histologically confirmed breast cancer with measurable confirmed metastatic disease in a known BRCA 1or 2 carrier, where chemotheraphy is the treatment of choice. • Patients with stable, treated brain metastases will be eligible providing informed consent can be given and that other sites of measurable disease are present. • Patients with bone metastases currently receiving bisphosphonates for palliation will be eligible providing other sites of measurable disease are present • WHO Perfomance Status 0, 1 or 2 (see Appendix 4) • Adequate haematology, biochemical indices (FBC, U & E´s) • LFT´s = Normal bilirubin, AST and/or ALT < 3 x ULN if Alk Phos >5 x ULN (or an isolated elevation AST/ALT of < 5 x ULN) • Adequate renal function (GFR > 30ml/min and normal urea and creatinine) • Written informed consent and able to comply with treatment and follow-up • Patients who have not received anthracycline based chemotherapy in the adjuvant setting may receive a non-taxane, anthracycline regimen as the first line metastatic treatment and enter the trial at confirmed progression (second line).
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E.4 | Principal exclusion criteria |
• Patients unfit for chemotherapy or those with neuropathy > grade 1(sensory or motor) • Known allergy to platinum compounds or to mannitol • Known sensitivity to taxanes • Previous tratment with a platinum chemotherapy drug, unless treatment was for non breast cancer related disease more than 10 years ago. • LFT´s = Abnormal bilirubin (> ULN), AST and/or ALT > 3 x ULN and Alk Phos > 5 x ULN (or an isolated elevation AST/ALT > 5 x ULN) • Patients with a life expectancy of less than 3 months • Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 10 years • Patients with bone limited disease or suitable for endocrine therapy alone • Other serious uncontrolled medical conditionsor concurrent medical illness likely to compromise life expectancy and/or the completion of trial therapy • Pregnant, lactating or potentially childbearing women not using adequate contraception (documentation of a negative serum HCG pregnancy test should be available for premenopausal women with intact reproductive organs, or women less than two years after the menopause. Fertile women and their partners must use a medically acceptable contraceptive throughtout the treatment period and for six months following cessation of treatment. Subjects must be made aware before entering the trial of the risk in becoming pregnant)
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary: Response and toxicity Secondary: Time to progression |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | 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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.5 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |