Hannah trial herceptin

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.

Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: final analysis of the randomised, two-cohort PrefHer study. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. Neoadjuvant and adjuvant trastuzumab in patients with HER2-positive locally advanced breast cancer NOAH : follow-up of a randomised controlled superiority trial with a parallel HER2-negative cohort.

Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Guidance for industry: pathological complete response in neoadjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval.

Published October Accessed November, Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer. N Engl J Med. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer ExteNET : 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial.

Save Preferences. Privacy Policy Terms of Use. This Issue. Views 14, Citations View Metrics. Twitter Facebook More LinkedIn. Brief Report. Study Design and Patients. Statistical Analysis. Long-term Safety. Back to top Article Information. Access your subscriptions. Access through your institution. Add or change institution. Free access to newly published articles. Purchase access. Rent article Rent this article from DeepDyve.

Access to free article PDF downloads. Save your search. Customize your interests. Create a personal account or sign in to:. Privacy Policy. Make a comment. We report associations between tpCR and event-free survival EFS from HannaH the largest population from a single study of patients presenting with newly diagnosed HER2-positive breast cancer treated with neoadjuvant-adjuvant trastuzumab to date plus long-term efficacy and safety.

Post-surgery, patients received adjuvant trastuzumab as randomised to complete 1 year of standard treatment. EFS rates per subgroup were estimated using the Kaplan-Meier method. Results were similar for subgroups, including oestrogen receptor status. PK samples were obtained after surgery Cycle Participants were evaluated following eight cycles of treatment and after surgery to assess for tpCR, defined as absence of neoplastic invasive cells in the breast and axillary lymph nodes according to pathologist examination.

Protocol-defined events included disease recurrence or progression local, regional, distant, contralateral or death from any cause. The percentage of participants who died at any time during the study was reported. OS was estimated by Kaplan-Meier analysis and defined as the time from randomization to death from any cause.

Participants provided PK samples for evaluation of anti-trastuzumab antibodies. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.

Lueck, Dr. Schrader und Dr. Medicina - S. Olsztyn, Poland, Centrum Onkologii - Instytut im. Siriraj Hosp. More Information. Publications automatically indexed to this study by ClinicalTrials.

JAMA Oncol. Epub May 9. 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. Epub Aug 9. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Breast Cancer. Phase 3. Study Type :.