Trial of Concurrent Versus Sequential Tamoxifen With Radiotherapy in Breast Cancer Patients
Status:
Unknown status
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
Two hundred and sixty patients with breast cancer will be accrued into the study. After
inclusion in the study, all the patients will be randomized into two arms. Arm 1 will receive
Tamoxifen given concurrently with radiotherapy while in Arm 2 radiotherapy will be given
followed by tamoxifen sequentially. The patients will be stratified for the following
factors: a) BCS (Breast conservative surgery) versus MRM (modified radical mastectomy) and b)
central lung distance (CLD) > 2 cm.
Patients in both arms will continue tamoxifen for a period of 5 years. The patients will be
evaluated by high-resolution computed tomography (HRCT) (baseline and at 2 years), serum
transforming growth factor (TGF) beta levels (baseline and at 6 months) and
diethylenetriaminepentaacetic acid (DTPA) aerosol clearance half life (baseline and at 6
months).