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

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Danish Breast Cancer Cooperative Group
• Collaborators: Danish Cancer Society; Novartis; The Danish Medical Research Council
• Treatments: Letrozole

Criteria

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