Abstract S6-03: DBCG 07-READ: A randomized phase III trial comparing six cycles of docetaxel and cyclophosphamide (DC) to three cycles of epirubicin and cyclophosphamide followed by three cycles of docetaxel (EC-D) in patients with early breast cancer

Background: DBCG 07-READ was designed to compare sequential EC followed by D with DC in patients with early, TOP2A normal breast cancer as a retrospective evaluation of the DBCG 89D trial suggested that these patients would not benefit from an anthracycline. Methods: This is a multicenter open-label randomized phase III trial. Three groups of women were eligible following completely resected unilateral invasive TOP2A normal (TOP2A gene to centromere 17 ratio of 0.8 to 2.0) breast cancer by mastectomy or breast conserving surgery in combination with axillary clearance or a negative sentinel node biopsy; 1: Age 18 to 39 years; 2: Age 40 to 75 years and estrogen receptor (ER) negative ( 20 mm. Eligible patients were required to have a Charlson Comorbidity (CC) Index Results: Between July 2008 and December 2012 we (12 DBCG centers) randomly assigned 2006 eligible patients to DC (N=1008) or EC-D (N=998). Patient and tumor characteristics were balanced by treatment groups. The median estimated potential follow-up is 5.4 years and the 5-year DFS was 88.0%; 95% CI 85.8 to 90.0 in the EC-D arm and 87.9%; 95% CI 85.7 to 89.9 in the DC arm. No significant difference in the risk of DFS events HR=1.03; 95% CI 0.80 to 1.32; p=0.84 or mortality HR=1.11; 95% 0.79 to 1.56; p=0.55 was observed in the intent to treat analysis. Patient-reported toxicity will be compared for the two chemotherapy regimens. Conclusion: The READ trial gives evidence to support no outcome benefit from anthracycline in patients with TOP2A normal ealy breast cancer. Citation Format: Ejlertsen B, Tuxen MK, Jakobsen EH, Jensen M-B, Knoop AS, Hoejris I, Ewertz M, Balslev E, Vestlev PM, Kenholm J, Nielsen DL, Bechmann T, Andersson M, Cold S, Nielsen HM, Maae E, Carlsen D, Mouridsen HT. DBCG 07-READ: A randomized phase III trial comparing six cycles of docetaxel and cyclophosphamide (DC) to three cycles of epirubicin and cyclophosphamide followed by three cycles of docetaxel (EC-D) in patients with early breast cancer [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr S6-03.