E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with advanced 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 |
The overall objective of the present trial is to find the optimal sequence of endocrine and cytotoxic treatment in patients with advanced breast cancer potenially sensitive to both modalities.
The primary endpoint is overall survival (OS) from day of randomisation.
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E.2.2 | Secondary objectives of the trial |
As secondary objective we will study the respons and progression pattern in the two treatment arms. This includes analyses of the respons to the first and second treatment modality, as well as various analyses of the times of first and second progression, TTP1 and TTP2.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- histologically proven breast cancer - Er+ or PgR+ - postmenopausal status - female age <75 - ambulant patients (ECOG<2) - metastatic or locally advanced breast cancer not having received systemic treatment for recurrent or metastatic disease - measurable or evaluable (See 7.1!) progressing metastases or local disease - organ functions and performance status adequate for conventional combination chemotherapy - complete initial work-up within 4 weeks prior to first treatment. - signed informed consent according to the local Ethics Committee requirements
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E.4 | Principal exclusion criteria |
- known HER2-positivity (3+ by immunohistochemistry or HER2 FISH/CISH +) - concomitant treatment with radiotherapy, endocrine, cytotoxic or experimental cancer therapy - presence of cerebral or leptomeningeal metastases - sclerotic bone-metastases only - previous or concurrent malignancies at other sites, except basal cell carcinoma and carcinoma cervicis uteri in situ (patients with bilateral breast cancer can be included) - patients with immediately life-threatening metastatic disease (CT first is recommended)
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is overall survival (OS) from day of randomisation.
As secondary objective we will study the respons and progression pattern in the two treatment arms. This includes analyses of the respons to the first and second treatment modality, as well as various analyses of the times of first and second progression, TTP1 and TTP2.
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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 | 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 | 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) | 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 | 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 | 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 |
anthracycline or a taxane or their combination |
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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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 duration of the trial will be approximately until December 2008. |
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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |