E2100: Phase III Avastin + Paclitaxel Primary endpoint: PFS –Other endpoints: ORR, OS, quality of life, safety Previously untreated LR/mBC N=722 Strat
{"Image DocumentName": "E2100: Phase III Avastin + Paclitaxel", "Image ImageDescription": "Previously untreated LR/mBC. N=722. Stratification factors: Disease-free interval. No. of metastatic sites. Adjuvant chemotherapy (yes vs no) ER status. Treat to disease. progression  Paclitaxela.  No crossover permitted. Treat to disease. progression. Paclitaxela + Avastin. 10 mg/kg q2w. Last updated September 2, This slide shows the study design for the E2100 phase III trial of weekly paclitaxel with or without Avastin as first-line therapy for LR/mBC. This was a multicentre randomised trial carried out by the Eastern Cooperative Oncology Group (ECOG) in the USA patients with chemotherapy-na\u00efve LR/mBC were randomised to receive paclitaxel (90 mg/m2/week for 3 weeks of a 4-week cycle) either alone (n=354) or combined with Avastin (10 mg/kg every 2 weeks; n=368). Randomisation was stratified by disease-free interval (<24 vs \u226524 months), number of metastatic sites (<3 vs \u22653), treatment with chemotherapy in the adjuvant setting (yes vs no) and oestrogen receptor status (positive vs negative vs unknown). Patients were treated until disease progression (as assessed by the investigator) or unacceptable toxicity. Patients in the paclitaxel-alone arm were not permitted to cross over to receive Avastin at disease progression. If patients in the Avastin plus paclitaxel arm discontinued either agent before disease progression, they were allowed to continue with single-agent therapy (Avastin or paclitaxel alone) until progression. The primary objective was to evaluate the efficacy of Avastin plus paclitaxel compared with paclitaxel alone as measured by PFS. This was defined as time from randomisation until disease progression (determined by ECOG review of investigator-reported data) or death from any cause. Secondary objectives included the evaluation of objective response rate, duration of response, overall survival, quality of life and toxicity. All patients were assessed for response until progressive disease, regardless of whether study therapy was continued until this point, and for survival for 5 years after randomisation. Reference. Miller KD, Wang M, Gralow J, et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med 2007;357:2666\u201376. Primary endpoint: PFS. Other endpoints: ORR, OS, quality of life, safety. a90 mg/m2 weekly for 3 weeks of a 4-week cycle. Miller et al. NEJM", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}