Trial Information

A Multimodality Treatment Approach to Patients With Inflammatory Cancer of the Breast and Locally Advanced Non-Inflammatory Stage III Breast Cancer and Stage IV Breast Cancer

This study is designed to evaluate the efficacy of high dose melphalan and autologous bone
marrow transplantation given as consolidation therapy to patients with inflammatory or
metastatic carcinoma of the breast in complete remission. All patients entered will receive
induction therapy with cyclophosphamide, adriamycin, methotrexate and 5-fluorouracil with
hormonal synchronization utilizing tamoxifen and premarin as in a previous Medicine Branch
protocol (MB-160C). Among patients with inflammatory carcinoma of the breast, pathologic
complete responders will receive irradiation to the breast and regional lymph nodes;
convertible partial responders and clinical complete responders with residual disease on
biopsy will undergo surgical resection of bulk disease followed by irradiation of the chest
wall and regional lymph nodes excluding the axilla. Both groups of responders will be
randomized to receive either systemic consolidation therapy with high dose melphalan (180
mg/M2 total dose over 3 days) and autologous bone marrow transplantation followed by
maintenance therapy or maintenance therapy alone. Complete responders in this
noninflammatory group will not receive further therapy since, historically, they have done
well following induction and local therapy, with maintenance therapy alone.

Patients with metastatic breast cancer will be assessed for response throughout induction
therapy. Complete and convertable partial responders will receive consolidative therapy and
be randomized to ABMT followed by 6 months of maintenance therapy vs. maintenance alone.