- •3-year event-free survival data in PrefHer were consistent with previous trials.
- •The overall safety profile during adjuvant treatment was as expected.
- •H SC was well tolerated and no new safety signals were identified.
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- Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I–III breast cancer (HannaH study): a phase 3, open-label, multicentre randomised trial.Lancet Oncol. 2012; 13: 869-878
- Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): an open-label randomised study.Lancet Oncol. 2013; 14: 962-970
- Patients' preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study.Ann Oncol. 2014; 25: 1979-1987
- Implications of subcutaneous or intravenous delivery of trastuzumab; further insight from patient interviews in the PrefHer study.Breast. 2015; 24: 166-170
- Patients' preference of trastuzumab administration (Subcutaneous versus Intravenous) in HER2-positive metastatic breast cancer: results of the randomised MetaspHer study.Eur J Cancer. 2017; 82: 230-236
- A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer.Cancer Med. 2016; 5: 389-397
- Subcutaneous trastuzumab (Herceptin®): a UK time and motion study in comparison with intravenous formulation for the treatment of patients with HER2-positive early breast cancer.AdvBreast Cancer Res. 2013; 2: 133-140
- Medical resource utilization for administration of trastuzumab in a New Zealand oncology outpatient setting: a time and motion study.Clin Outcomes Res. 2015; 7: 423-430
- Administrative risk quantification of subcutaneous and intravenous therapies in Italian centers utilizing the failure mode and effects analysis approach.Clin Outcomes Res. 2016; 8: 353-359
Tjalma WAA, Van den Mooter T, Mertens T, et al. Trastuzumab IV versus SC: atime, motion and cost assessment in a lean operating day care oncology unit. Multidisciplinary Breast Clinic, Antwerp University Hospital – University of Antwerp, Belgium. Presented at the San Antonio breast cancer Symposium, San Antonio, TX, 6–10 December 2016 (Poster P4-21-15).
De Cock, E, Pan Y, Tao S, et al. Time savings with transtuzumab subcutaneous (SC) injection verse trastuzumab intravenous(IV) infusion: a time and motion study in 3 Russian centers. Presented at the Annual European ISPOR Congress, Amsterdam, The Netherlands, 8–12 November 2014 (Poster PCN221).
- Hospital resources consumption associated with trastuzumab treatment in breast cancer in Portugal.Value Health. 2013; 16: A418
- Is Herceptin((R)) (trastuzumab) by subcutaneous a mini revolution? Pharmaco-economic study.Bull Cancer. 2015; 102: 270-276
- Societal cost of subcutaneous and intravenous trastuzumab for HER2-positive breast cancer – an observational study prospectively recording resource utilization in a Swedish healthcare setting.Breast. 2016; 29: 140-146
- Early and metastatic HER2-positive breast cancer: subcutaneous trastuzumab.2013[Accessed 26 May 2017])
- Cost-minimization analysis of trastuzumab intravenous versus trastuzumab subcutaneous for the treatment of patients with HER2+ early breast cancer and metastatic breast cancer in Greece.Value Health. 2014; 17: A640-A641
- Economic impact of using subcutaneous trastuzumab.Value Health. 2014; 17: A641
- HannaH phase III randomised study: association of total pathological complete response with event-free survival in HER2-positive early breast cancer treated with neoadjuvant-adjuvant trastuzumab after 2 years of treatment-free follow-up.Eur J Cancer. 2016; 62: 62-75
- Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis.Lancet. 2014; 38: 164-172
- 5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial.Lancet Oncol. 2016; 17: 791-800
- Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer.N Engl J Med. 2005; 353: 1673-1684
- Sequential versus concurrent trastuzumab in adjuvant chemotherapy for breast cancer.J Clin Oncol. 2011; 29: 4491-4497
- Adjuvant trastuzumab in HER2-positive breast cancer.N Engl J Med. 2011; 365: 1273-1283
- 6 months versus 12 months of adjuvant trastuzumab for patients with HER2-positive early breast cancer (PHARE): a randomised phase 3 trial.Lancet Oncol. 2013; 14: 741-748
- Switching between intravenous and subcutaneous trastuzumab: safety results from the PrefHer trial.Breast. 2017; 34: 89-95
- Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial.J Clin Oncol. 2007; 25: 3859-3865
- Cardiac safety analysis of doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab in the north central cancer treatment group N9831 adjuvant breast cancer trial.J Clin Oncol. 2008; 26: 1231-1238
- Longer-term assessment of trastuzumab-related cardiac adverse events in the herceptin adjuvant (HERA) trial.J Clin Oncol. 2010; 28: 3422-3428
- Independent adjudication of symptomatic heart failure with the use of doxorubicin and cyclophosphamide followed by trastuzumab adjuvant therapy: a combined review of cardiac data from the national surgical adjuvant breast and bowel project B-31 and the north central cancer treatment group N9831 clinical trials.J Clin Oncol. 2010; 28: 3416-3421
- Seven-year follow-up assessment of cardiac function in NSABP B-31, a randomized trial comparing doxorubicin and cyclophosphamide followed by paclitaxel (ACP) with ACP plus trastuzumab as adjuvant therapy for patients with node-positive, human epidermal growth factor receptor 2-positive breast cancer.J Clin Oncol. 2012; 30: 3792-3799
- Trastuzumab-associated cardiac events at 8 years of median follow-up in the herceptin adjuvant trial (BIG 1-01).J Clin Oncol. 2014; 32: 2159-2165
- Cardiac toxicity events in the PHARE trial, an adjuvant trastuzumab randomised phase III study.Eur J Cancer. 2015; 51: 1660-1666
- Long-term cardiac safety analysis of NCCTG N9831 (alliance) adjuvant trastuzumab trial.J Clin Oncol. 2016; 34: 581-587
Jung KH, Ataseven B, Verrill M, et al. Adjuvant subcutaneous trastuzumab for HER2-positive early breast cancer: phase III SafeHer study subgroup analyses of body weights, active medical conditions, safety and tolerability. Presented at the European Society for Medical Oncology 2016 Congress, Copenhagen, Denmark, 7–10 October 2016 (Poster 211P).
- Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer.N Engl J Med. 2017; 377: 122-131
- Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer.N Engl J Med. 2012; 366: 109-119
- Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer.N Engl J Med. 2015; 372: 724-734
Woodward N, de Boer RH, Redfern A, et al. Updated safety results from the first multicenter, open-label, phase IIIb study investigating the combination of pertuzumab with subcutaneous trastuzumab and a taxane in patients with HER2-positive metastatic breast cancer (SAPPHIRE). Presented at the san Antonio breast cancer Symposium, San Antonio, TX, 6–10 December 2016 (Poster P4-21-31).
Kümmel S, Abraham J, Martín M, et al. MetaPHER phase IIIb multicenter, open-label, single-arm safety study of subcutaneous trastuzumab in combination with pertuzumab and docetaxel in patients with HER2-positive advanced breast cancer: first results. Presented at the San Antonio breast cancer Symposium, san Antonio, TX, 6–10 December 2016 (Poster P4-21-42).