Trial of Endocrine Against Locoregional Therapy First in Postmenopausal Women With Early Breast Cancer

Randomized Trial of Endocrine Therapy Against Locoregional Therapy First. A DBCG Trial in Postmenopausal Patients With Operable Hormone Receptor Positive Tumors Larger Than 2 cm.

The hypothesis to be addressed in this randomized phase III trial is that 4 months of letrozole may be superior to surgery as primary therapy for early stage hormone receptor positive breast cancer in postmenopausal women, provided that these patients will receive definitive and radical surgery and adjuvant therapies as otherwise indicated at the completion of preoperative letrozole.

Inclusion Criteria:

• Informed consent
• Age 60 years or older
• Measurable non-metastatic and non-inflammatory breast cancer
• Tumor of 2 cm or larger
• ER and/or PgR positive tumor
• Co-morbidity index 0 - 3, e.g., no other serious medical condition

Exclusion Criteria:

• Prior medical therapy for a malignant disease, including aromatase inhibitors
• Distant metastasis
• Need for chemotherapy
• Past or current history of other neoplasms (except for curative treated basal skin cancer or in situ carcinoma of the cervix uteri)
• Treatment with a non-approved drug within 30 days