Primary breast cancer in postmenopausal patients MedDRA version: 8.0 Level: PT Classification code 10057654
Conditions
Interventions
Product Name: Letrozole
Product Code: CGS20267
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: CGS 20267
Other descriptive name: Letrozole
Concentration unit: mg milligram(s)
Concentrati
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 40 IU/L) or postmenopausal estradiol levels ( 3.0 x 10e9/L, platelets > 100.0 x 10e9/L, and hemoglobin > 10 g/dL). · Adequate hepatic function (bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: · Disease free survival (DFS) · Quality of life (EORTC QLQ-C30 + BR23) · Safety and tolerability ;Primary end point(s): Absence of recurrence during 24 month of treatment with Letrozole or progression of disease. | — |
Countries
Germany
Outcome results
None listed