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Background: In early breast cancer patients the transformed epithelial cells are thought to be sensitive to transforming growth factor beta1 (TGFbeta1)-mediated growth arrest. TGFbeta1 may therefore act as an anti-tumour promoter. However, in advanced breast cancer resistance to such TGFbeta1 action develops. Neoplastic cells produce TGFbeta1, which may enhance tumour invasion and metastasis, mainly by intensifying angiogenesis, which is an immunosuppressive action. In the light of the potential role of TGFbeta1 in breast cancer pathogenesis, an understanding of the effect of applied therapeutic methods on plasma TGFbeta1 concentration is essential., Objective: To investigate the effect of adjuvant chemotherapy on plasma transforming growth factor beta1 (TGFbeta1) concentration in breast cancer patients with metastases to axillary lymph nodes., Method: Fifteen stage II breast cancer patients on adjuvant chemotherapy with cyclophosphamide, methotrexate and 5-fluorouracil (CMF) were studied along with 15 healthy premenopausal women., Results: Plasma TGFbeta1 concentration (determined by the ELISA method) in the breast cancer patients did not differ significantly from that of the healthy women. Adjuvant CMF chemotherapy significantly decreased plasma TGFbeta1 concentration in those pre-menopausal breast cancer women with metastases to axillary lymph nodes., Conclusion: The possible pathogenic action of this growth factor in stage II breast cancer disease warrants further investigation to elucidate whether the induced decrease of blood TGFbeta1 concentration is essential to successful chemotherapy.