ER positive and/or PR positive early breast cancer Cancer Breast
Conditions
Interventions
After providing consent, patients will be screened for eligibility.
Eligible patients will be registered at any time up to 2 years (+/- 3 months) of tamoxifen treatment. Tamoxifen treatment had to be
Sponsors
Thai Breast Cancer Study Group (Thailand)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients with stage I, II or IIIa adenocarcinoma of the breast at diagnosis. Patients with breast cancer whose tumor has been completely removed macroscopically and margins of the resected tumor have been microscopically free of tumor. If appropriate, additional local (e.g. radiotherapy) and/or systemic (i.e. adjuvant chemotherapy) treatments are allowed. 2. Postmenopausal status defined by one of the following: a. Age =55 years with cessation of menses b. Age 40 IU/l) or postmenopausal estradiol levels (<5 ng/dl) or according to the definition of 'postmenopausal range' for the laboratory involved d. Bilateral oophorectomy 3. Patients whose tumors are either ER+ and/or PR+ (defined as ER and/or PR =10 fmol/mg cytosol protein; or =10% of the tumor cells positive by immunohistochemical evaluation) 4. Under tamoxifen therapy for 2 years before randomization 5. At randomization, patients must have no clinical or radiological evidence of distant metastasis, and no other concomitant malignancy (confirmed by mammography, chest X-ray or computed tomography [CT] scan, bone scan and liver US) 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0?2 7. No prior treatment with letrozole 8. Patients must be accessible for follow-up 9. Signed written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with any clinical or radiological evidence of distant spread of their disease at any point before randomization 2. 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 human immunodeficiency virus (HIV) are excluded. 3. Total serum calcium >2.75 mmol/l (11.0 mg/dl) 4. White Blood Cell Count (WBC) 3 upper limit of normal (ULN) in combination with other laboratory and clinical abnormalities indicating liver insufficiency to a degree that precludes dosing with letrozole (Child-Pugh grade C) 6. Patients with abnormal renal function as defined by a serum creatinine =3 mg/dl (265.2 mmol/l) 7. Previous history of fracture within 2 years 8. Patients treated with other systemic investigational drug(s) and/or device(s) within the past 30 days 9. History of non-compliance to medical regimens and patients who are considered potentially unreliable 10. Mental illness that precludes the patient from giving informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare these treatment regimens in terms of disease free survival (DFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Compare these treatment regimens in terms of overall survival (OS) 2. Compare these treatment regimens in terms of safety and tolerability in the Thai patient population | — |
Countries
Thailand
Outcome results
None listed