A phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following 4 to 6 years of prior adjuvant endocrine therapy for post-menopausal women with hormone-receptor positive, node positive early stage breast cancer

European Institute of Oncology (IEO) (Italy)0 sites4,884 target enrollmentNovember 3, 2009

Overview

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29158011 results (added 10/09/2019)

Registry

who.int

Start Date

November 3, 2009

End Date

December 31, 2018

Last Updated

3 years ago

Study Type

Interventional

Sex

Female

Sponsor

European Institute of Oncology (IEO) (Italy)

•1\. Patients must be post\-menopausal; definitive confirmation of post\-menopausal status is required
•2\. Patients must be accessible for follow\-up
•3\. At diagnosis, patients must have had operable, non\-inflammatory breast cancer
•4\. Patients must be clinically disease\-free at randomisation
•5\. Patients must have had steroid hormone receptor positive tumours (oestrogen receptor \[ER] and/or progesterone receptor \[PgR]), determined by immunohistochemistry, after primary surgery and before commencement of prior endocrine therapy
•6\. Following primary surgery, eligible patients must have had evidence of lymph node involvement either in the axillary or internal mammary nodes, but not supraclavicular nodes
•7\. There must have been no evidence of recurrent disease or distant metastatic disease at any time prior to randomisation
•8\. Patients must have had proper local treatment including surgery with or without radiotherapy for primary breast cancer with no known clinical residual loco\-regional disease
•9\. Patients must have clinically adequate hepatic function
•10\. Patients must have completed 4 to 6 years of prior adjuvant endocrine therapy with SERMs, AI or a sequential combination of both. When calculating 4 \- 6 years, neoadjuvant endocrine therapy should not be included.

•1\. Patients who have had bilateral breast cancer
•2\. Patients who have had a bone fracture due to osteoporosis at any time during the 4\-6 years of prior endocrine SERM/AI therapy
•3\. Patients who have had any previous or concomitant malignancy EXCEPT adequately treated: basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, contra\- or ipsilateral in situ breast carcinoma
•4\. Patients who have had any other non\-malignant systemic diseases (cardiovascular, renal, lung, etc.) that would prevent prolonged follow\-up
•5\. Patients with psychiatric, addictive, or any disorder which compromises compliance with protocol requirements