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Tamoxifen Versus Control After Adjuvant, Risk-Adapted Chemotherapy in Postmenopausal, Receptor-Negative Patients With Breast Cancer: A Randomized Trial (GABG-IV D-93)—The German Adjuvant Breast Cancer Group

From the Universitäts-Frauenklinik, Frankfurt; Medizinische Biometrie und Statistik, Universitätsklinikum Freiburg; Universitäts-Frauenklinik, Kiel; Rot-Kreuz-Krankenhaus, München; Universitäts-Frauenklinik, Heidelberg; Universitäts-Frauenklinik, Marburg; Universitätsklinikum, Magdeburg; Senologisches Zentrum, Kassel; and Prosper Hospital, Recklinghausen, Germany

Address reprint requests to Manfred Kaufmann, MD, Theodor-Stern-Kai 7, 60596 Frankfurt, Germany; e-mail: m.kaufmann{at}em.uni-frankfurt.de

PURPOSE: To investigate the effect of adjuvant sequential tamoxifen after chemotherapy in postmenopausal patients with hormone receptor–negative breast cancer.

METHODS: Patients were randomly assigned to oral tamoxifen (30 mg daily for 5 years; n = 421) or no additional treatment (n = 408) after risk-adapted polychemotherapy consisting of three 28-day cycles of CMF (cyclophosphamide, 500 mg/m², methotrexate, 40 mg/m², and fluorouracil, 600 mg/m²) in patients with negative or one to three positive lymph nodes and four 21-day cycles of epirubicin 90 mg/m², cyclophosphamide 600 mg/m² followed by three cycles of CMF in patients with four to nine positive lymph nodes.

RESULTS: Thirty-six percent of the patients included were older than 60 years, 63% were node negative, 13% had four to nine positive nodes, 55% had tumor grade 3, and 41% received breast-preserving surgery. At 5.3 years’ median follow-up, the first event of failure (recurrence, secondary tumor, or death) had occurred in 123 patients in the tamoxifen group and 107 patients of the control group. Event-free survival rates after 5 years were 70.3% (95% CI, 65.5% to 75.0%) and 72.8% (95% CI, 68.2% to 77.5%) for the tamoxifen and control groups, respectively. The estimated hazard ratio of tamoxifen versus control was 1.13 (95% CI, 0.87 to 1.48; P = .34), which gives no indication of an additional benefit of tamoxifen in these patients.

CONCLUSION: This study contributes substantially to finalization of the presently emerging evidence that tamoxifen does not benefit women with receptor-negative breast cancer after chemotherapy.

Supported by Grants from the Deutsche Krebshilfe, AstraZeneca, Germany, and Pharmacia, Germany.

Authors’ disclosures of potential conflicts of interest are found at the end of this article.

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