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-positive eBC reported. The co-primary endpoints of pharmacokinetics and efficacy met their pre-specified criteria. Plasma concentration measured just before surgery was at least as high for the SC as for the IV formulation (69.0 and 51.8 µg/mL, respectively). In addition, efficacy as determined by pathological complete response (pCR; complete eradication of the tumour cells in the breast), was in the same range as in patients who received the and SC IV formulations(45.4% and 40.7%, respectively). The overall safety profile was consistent with that expected from treatment with Herceptin and standard chemotherapy in this setting. The results were presented at the 8th European Breast Cancer Conference (EBCC-8) in Vienna (Abstract # 1BA) [6].
02/04/2012 10:25:29
Q4 11: Positive top-line data from HANNAH (NCT00950300) trial, reported in Oct, has been accepted for presentation at EBCC 2012 [4].
06/03/2012 15:28:10
Oct 11: Positive results from the PIII showed SC injection of trastuzumab had comparable results to the IV infusion. The SC administration takes around 5 minutes to administer whereas the IV formulation (the current standard) takes around 30 minutes to infuse. Since the subcutaneous administration is an injection under the skin it may allow patients to spend less time in hospital receiving their treatment versus the intravenous method. The ready to use formulation may also significantly reduce pharmacy time as no medicine preparation time is required [3].
19/10/2011 09:35:05
NCT00950300: a PIII randomized open-label study comparing the pharmacokinetics, efficacy and safety of subcutaneous vs IV trastuzumab in 593 women with HER2-positive early breast cancer. Patients with operable or locally advanced breast cancer will receive pre-operative treatment with 8 cycles of chemotherapy (docetaxel followed by 5-FU/ epirubicin/ cyclophosphamide) concurrent with either SC or IV trastuzumab. After surgery patients will receive a further 10 cycles of trastuzumab SC or IV to complete 1 year of treatment. Patients will be followed for up to 2 years after the end of treatment. The primary outcome measures are: trastuzumab serum concentrations, throughout cycles 1 to 8; pathologic complete response after surgery between cycles 8 and 9. The study started in Sep 09 and is due to complete Jun 14 [1].
22/08/2011 09:00:12
Evidence Based eva luations
NICE (MPC) http://publications.nice.org.uk/esnm13-early-and-metastatic-her2-positive-breast-cancer-subcutaneous-trastuzumab-esnm13
NHSC http://www.nhsc-healthhorizons.org.uk/files/downloads/1052/1558.3c8869bc49189f6393ee111d4cd627c5.pdf
References
Available only to registered users
Category
BNF Category: Other antineoplastic drugs (08.01.05)
Pharmacology: HER2 monoclonal antibody co-formulated with recombinant human hyaluronidase
Epidemiology: Breast cancer is the most common cancer in women, with about 45,000 new cases |
