Status: Treatment Phase & Follow-up

A randomized phase III study comparing biweekly and tailored epirubicin + cyclophosphamide followed by biweekly tailored docetaxel (dtEC→dtT) (A-arm) versus three weekly epirubicin + cyclophosphamide, 5-fluorouracil followed by docetaxel (FEC→T) (B-arm) in lymph node positive or high-risk lymph node negative breast cancer patients – a continuation of the feasibility part of the SBG 2004-1 study

Coordinating Investigator: Richard Greil (Salzburg)
Start of study: 02/2007 (global), 10/2007 (national)
Sample size: 2.000
Sponsor: ABCSG (Co-Sponsor) and SBG

Description and status:

This controlled, randomized, adjuvant phase III study examines the effects of a dose-dense chemotherapy tailored to the individual breast cancer patient compared with standard chemotherapy. In the course of the tailored chemotherapy, affected women received the active ingredients epirubicin and cyclophosphamide (dtEC) at the beginning of therapy and were then treated with the active ingredient docetaxel (dtT) after a three-week break. The individually assessed dose was based on changes in blood count triggered by the therapy. This therapy impact on the blood count varies between patients. The control group was treated with standard chemotherapy starting with fluorouracil, epirubicin und cyclophosphamide (FEC), after a three-week break resuming with docetaxel (T) without any adjustments based on the laboratory values. This project is conducted as a collaboration between the Scandinavian Breast Group (SBG) and the ABCSG and is currently in the follow-up phase. Austrian, Swedish, and German sites are involved with 2.017 enrolled patients in total. In Austria, 465 patients at 16 sites could be enrolled in this study. First results show no significant difference in the 5-year overall and disease-free survival between the two arms. However, with the individually tailored therapy, a significantly better event-free survival could be observed compared to the control group. Results were already presented at international breast cancer conferences, such as ASCO 2016, ESMO 2017, and were also successfully published (Foukakis T et al, JAMA 2016).

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