Breast Cancer Clinical Trial
Official title:
A Randomized Trial of Concurrent Versus Sequential Tamoxifen With Radiotherapy to Assess the Extent of Pulmonary Fibrosis and Disease Related Control and Survival in Breast Cancer Patients
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).
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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