Jul 13: Recommended approval in the EU for the treatment of patients with HER2-positive breast cancer [11].
01/07/2013 09:10:22
Mar 12: Filed in EU [5].
09/03/2012 22:00:54
EU filing planned 2012 [2].
07/09/2011 17:04:03
Trial or other data
Aug 13: NCT01926886 is a single arm multi-centre PIII study investigating the at home administration, by a health care professional, of s.c. trastuzumab for the treatment of 100 patientswith HER2-positive early breast cancer. The primary outcome is safety. The study starts Sep 13 and is due to complete May 17 [13].
22/08/2013 11:51:28
Aug 13: Randomised PrefHer study (NCT01401166) assessing patient preference for either SC or IV trastuzumab published in Lancet Oncology. 236 women aged 18 years or older with HER2-positive, histologically confirmed primary invasive breast adenocarcinoma, no evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy (neoadjuvant or adjuvant), an ECOG performance status of 0 or 1, and a baseline left-ventricular ejection fraction of 55% or more before the first dose of trastuzumab received four cycles of 600 mg fixed-dose SC adjuvant trastuzumab via a single-use injection device or hand-held syringe followed by four cycles of standard IV trastuzumab, or the reverse sequence. SC trastuzumab via the single-use injection device was preferred by 216 patients (91·5% [95% CI 87·2—94·7]; p<0·0001). Only 16 patients preferred IV trastuzumab (6·8% [3·9—10·8]), & four had no preference (1·7% [0·5—4·3]). Clinician-reported adverse events occurred in 141 of 242 (58%) pts during the pooled SC periods & 105 of 241 (44%) pts during the pooled IV periods; seven (3%) & five (2%) were grade 3, no pts had a grade 4 or 5 event. The most common grade 3 adverse event was influenza (0·8%) [12].
22/08/2013 10:30:03
Aug 12: HannaH published early online in Lancet Oncology [10].
10/08/2012 10:07:07
Hyaluronidase facilitates penetration & dispersion of trastuzumab by temporarily digesting hyaluronan, a major component of extracellular matrix in tissues such as skin [9].
01/05/2012 09:15:35
Apr 12: NCT01566721 a PIII prospective, two-cohort non-randomized, multi-centre, multinational, open label study to assess the safety of assisted- and self-administered subcutaneous trastuzumab as adjuvant therapy in 2,500 patients with operable HER2-positive early breast cancer [SafeHer Study]. The study started Mar 12 [7]
02/04/2012 14:42:33
Mar 12: Results from the PIII HannaH study in women with HER2-positiv