Phase III randomised trial comparing intense dose-dense chemotherapy to tailored dose-dense chemotherapy in high-risk early breast cancer (GAIN-2)

2021 ◽  
Vol 156 ◽  
pp. 138-148
Author(s):  
Volker Möbus ◽  
Hans-Joachim Lück ◽  
Ekkehart Ladda ◽  
Peter Klare ◽  
Marcus Schmidt ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Early Breast Cancer ◽  
Randomised Trial ◽  
Phase Iii ◽  
Dose Dense

A randomized phase III trial comparing two dose-dense, dose-intensified approaches (EPC and PM(Cb)) for neoadjuvant treatment of patients with high-risk early breast cancer (GeparOcto).

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. TPS1101-TPS1101
Author(s):  
Andreas Schneeweiss ◽  
Volker Moebus ◽  
Jens Uwe Blohmer ◽  
Serban Dan Costa ◽  
Carsten Denkert ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Early Breast Cancer ◽  
Neoadjuvant Treatment ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Dose Dense

German Adjuvant Intergroup Node-Positive Study: A Phase III Trial to Compare Oral Ibandronate Versus Observation in Patients With High-Risk Early Breast Cancer

2013 ◽  
Vol 31 (28) ◽  
pp. 3531-3539 ◽  
Author(s):  
Gunter von Minckwitz ◽  
Volker Möbus ◽  
Andreas Schneeweiss ◽  
Jens Huober ◽  
Christoph Thomssen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Early Breast Cancer ◽  
Data Monitoring Committee ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Positive Study ◽  
Node Positive ◽  
Dose Dense

Purpose Bisphosphonates prevent skeletal-related events in patients with metastatic breast cancer. Their effect in early breast cancer is controversial. Ibandronate is an orally and intravenously available amino-bisphosphonate with a favorable toxicity profile. It therefore qualifies as potential agent for adjuvant use. Patients and Methods The GAIN (German Adjuvant Intergroup Node-Positive) study was an open-label, randomized, controlled phase III trial with a 2 × 2 factorial design. Patients with node-positive early breast cancer were randomly assigned 1:1 to two different dose-dense chemotherapy regimens and 2:1 to ibandronate 50 mg per day orally for 2 years or observation. In all, 2,640 patients and 728 events were estimated to be required to demonstrate an increase in disease-free survival (DFS) by ibandronate from 75% to 79.5% by using a two-sided α = .05 and 1-β of 80%. We report here the efficacy analysis for ibandronate, which was released by the independent data monitoring committee because the futility boundary was not crossed after 50% of the required DFS events were observed. Results Between June 2004 and August 2008, 2,015 patients were randomly assigned to ibandronate and 1,008 to observation. Patients randomly assigned to ibandronate showed no superior DFS or overall survival (OS) compared with patients randomly assigned to observation (DFS: hazard ratio, 0.945; 95% CI, 0.768 to 1.161; P = .589; OS: HR, 1.040; 95% CI, 0.763 to 1.419; P = .803). DFS was numerically longer if ibandronate was used in patients younger than 40 years or older than 60 years compared with patients age 40 to 59 years (test for interaction P = .093). Conclusion Adjuvant treatment with oral ibandronate did not improve outcome of patients with high-risk early breast cancer who received dose-dense chemotherapy.

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