Return to Clinical Trials Search Results

Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus Radiation Therapy for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast

Objectives In the defined good-risk group, assess the role of whole breast radiation plus/minus tamoxifen compared to wide excision to negative margins alone plus/minus tamoxifen, in decreasing or delaying the appearance of local failure, both invasive and in situ, and preventing the need for mastectomy. Assess distant disease free survival to affirm the hypothesis that the proportion of patients in either arm who fail with progression to invasive local disease can be successfully salvaged with further definitive local therapy and adjuvant systemic therapy as is appropriate to the individual case. Adopt a working pathology classification system for DCIS, which can be taught to and uniformly applied by the community pathologist. This will include processing the specimen, assessing extent of disease, margin assessment, and the grading of the lesion. Pathologic relationship of any calcium present to the DCIS will also be noted. Establish a registry for patients with an epidemiological questionnaire, for companion studies of biomarkers and genetics, to be done at a later time when research in this area has identified useful markers. Tissue and blood will be banked from each patient who agrees to participate in this aspect of the study. Establish a tissue bank of patients who progress to local failure in the study breast.

Objectives In the defined good-risk group, assess the role of whole breast radiation plus/minus tamoxifen compared to wide excision to negative margins alone plus/minus tamoxifen, in decreasing or delaying the appearance of local failure, both invasive and in situ, and preventing the need for mastectomy. Assess distant disease free survival to affirm the hypothesis that the proportion of patients in either arm who fail with progression to invasive local disease can be successfully salvaged with further definitive local therapy and adjuvant systemic therapy as is appropriate to the individual case. Adopt a working pathology classification system for DCIS, which can be taught to and uniformly applied by the community pathologist. This will include processing the specimen, assessing extent of disease, margin assessment, and the grading of the lesion. Pathologic relationship of any calcium present to the DCIS will also be noted. Establish a registry for patients with an epidemiological questionnaire, for companion studies of biomarkers and genetics, to be done at a later time when research in this area has identified useful markers. Tissue and blood will be banked from each patient who agrees to participate in this aspect of the study. Establish a tissue bank of patients who progress to local failure in the study breast.