E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Este estudio es para evaluar el uso de letrozol frente a anastrozol en el tratamiento adyuvante en pacientes de elevado riesgo. La población en estudio son mujeres posmenopáusicas que recientemente hayan sufrido su primera cirugía de cáncer de mama y con afectación ganglionar y receptores hormonales. La primera cirugía puede haber sido una mastectomia total, una mastectomia parcial o una cuadrantectomia de su cáncer de mama primario. |
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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 compare the rate of disease free survival (DFS) at 5 years in postmenopausal women with hormone receptor and lymph node positive breast cancer randomized between letrozole and anastrozole. |
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E.2.2 | Secondary objectives of the trial |
• To compare the general safety between the two treatment arms. • To compare the two treatment groups in a descriptive manner with the other indicators of efficacy including overall survival, breast cancer specific survival, time to development of distant metastases and time to development of contra lateral breast cancer. • Compare percent change in BMD between the two arms • Compare the effects of treatment on serum lipid profiles in both treatment arms • Compare the incidence of clinical fractures between the two treatment arms |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• provision of written informed consent • undergone a total mastectomy, a lumpectomy, or a quadrantectomy for primary breast cancer. • the date of randomization must be no more than: • 4 weeks from completion of surgery or. • 4 weeks after completion of adjuvant chemotherapy. Note adjuvant radiation and endocrine therapy e.g. letrozole and anastrozole can be given at the same time as radiotherapy due to non-overlapping toxicity profile. • presence of node positive disease. • receptor-positive tumors, defined ER ≥10 fmol/mg cytosol protein; or ≥10% of the tumor cells positive by immunocytochemical evaluation. • postmenopausal whether induced by surgery, radiotherapy or chemotherapy, or by being naturally amenorrheic, for 1 year or more if younger than 50 and for 6 months if 50 or older. • postmenopausal levels of FSH/LH/E2 (follicle stimulating hormone, luteinizing hormone, estrogen) according to the definition of “postmenopausal range” for the laboratory involved. • WBC ≥ 3.0 x 109/L, granulocytes ≥ 1.5 X 109/L and platelets ≥ 100 x 109/L. • AST/SGOT or ALT/SGPT ≤ 3 times ULN. • serum creatinine ≤ 2 times ULN. |
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E.4 | Principal exclusion criteria |
• presence of metastatic disease. • concomitant or prior bilateral breast cancer. • previous or concomitant other (non-breast cancer) malignancy within the previous 5 years. • presence of other non-malignant systemic diseases which may prevent prolonged follow-up. • if no history of previous coronary heart disease but has at least two other coronary heart disease risk factors: LDL ≥160 mg/dL OR if fewer than two other coronary heart disease risk factors: LDL ≥190 mg/dL. • total fasting cholesterol ≥ 240 mg/dL. • patients on lipid-lowering agents, diet, or other measures for hyperlipidemia at baseline. • progressed on neoadjuvant endocrine therapy • hormone replacement therapy (HRT) within 4 weeks before trial treatment was initiated. • adjuvant anti-estrogen therapy for more than 1 month immediately following surgery, radiotherapy and/or chemotherapy. • Breast cancer chemoprevention with anti-estrogens if less than 18 months between stopping and diagnosis of breast cancer. • Severe hepatic dysfunction defined as Child-Pugh grade C. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | 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) | 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
| 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
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 | 7 |