E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary breast cancer in postmenopausal patients |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057654 |
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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 |
It is the aim of this prospective one arm phase III clinical study to evaluate recurrence in postmenopausal patients with breast cancer during 24 months of Letrozole treatment.
· Rate of patients without recurrence after 24 months of Letrozole treatment.
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E.2.2 | Secondary objectives of the trial |
· Disease free survival (DFS) · Quality of life (EORTC QLQ-C30 + BR23) · Safety and tolerability
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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. · Age > 18 years. · Performance status 0-2 (ECOG). · Compliant postmenopausal, i.e. at time of tumor diagnosis, women with primary operable breast cancer after complete surgery and suitable for endocrine treatment after complete surgery and suitable for endocrine treatment. · Age 55 years or older with cessation of menses. · Age <55 but no spontaneous menses for at least 1 year. · Age <55 and spontaneous menses within the past 1 year, but currently amenorrheic (e.g., spontaneous, or secondary to hysterectomy), and with postmenopausal gonadotrophin levels (luteinizing hormone and follicle stimulating hormone levels >40 IU/L) or postmenopausal estradiol levels (<5ng/dL) or according to the definition of “postmenopausal range” for the laboratory involved. · Nodal status negative or positive. · Hormone receptor positive (defined as ER and/or PgR higher or equal 10 fmol/mg cytosol protein; or higher or equal 10% of the tumor cells positive by immunohistochemical evaluation). · Adequate marrow function (WBC > 3.0 x 10e9/L, platelets > 100.0 x 10e9/L, and hemoglobin > 10 g/dL). · Adequate hepatic function (bilirubin < 30 µmol/L, ALT (SGPT) or AST (SGOT) < 1.5 x UNL of the institution).
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E.4 | Principal exclusion criteria |
· Patients with clinical or radiological evidence of metastatic breast cancer · Breast Cancer which is ER and PgR negative or unknown · Inflammatory breast cancer · Abnormal renal function as evidenced by a calculated creatinine clearance < 30 mL/min. Creatinine clearance (CrCl) is calculated using the Cockcroft- Gault formula:
CrCl = [140-age (years)] x weight (kg) / [72 x serum creatinine (mg/dL)] x {x 0.85 for female patients} · Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures. · Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants). · Known hypersensitivity to Zometa® (Zoledronic acid) or other bisphosphonates. · Patients with previous or concomitant malignancy (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease-free for five years. · Patients with other non-malignant systemic diseases including uncontrolled infections, uncontrolled type 2 diabetes mellitus, uncontrolled thyroid dysfunction, cardiovascular, renal, hepatic, and lung diseases which would prevent prolonged follow-up. Patients with previous history of thrombosis or thromboembolism can be included only if medically suitable. Patients with a known history of HIV are excluded. · Severe physical or psychological concomitant diseases that might impair compliance with the provisions of the study protocol or that might impair the assessment of drug or patient safety, e.g. clinically significant ascites, cardiac failure, NYHA III or IV, clinically relevant pathologic findings in ECG. · Patients treated with systemic investigational drug(s) and/or device(s) within the past 30 days or topical investigational drugs within the past 7 days. · History of non-compliance to medical regimens and patients who are considered potentially unreliable. · Mental illness that precludes the patient from giving informed consent.
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E.5 End points |
E.5.1 | Primary end point(s) |
Absence of recurrence during 24 month of treatment with Letrozole or progression of disease. |
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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 | 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 | 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 | 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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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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
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 |