Numerous treatment options are available to patients with HER2-positive (HER2+) breast cancer. The used drugs as well as the sequence in which they are used may vary between countries. Frequently used in unresectable LA/mBC is trastuzumab, usually proposed in various combinations, as well as pertuzumab, trastuzumab-emtasine, and lapatinib. Only limited data are available on the treatment patterns used in clinical practice. This study is part of a global umbrella study and will meet the need for real world data on treatment patterns and outcomes in HER2+ unresectable LA or mBC. A descriptive analysis may identify possible associations between patient characteristics, treatments and outcomes. The study will collect data for up to 8 years, thus as new treatments become available, the study will also offer a unique opportunity to gain insight into evolving treatment options.
SAMANTHA is a prospective, multicenter non-interventional post authorization safety study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2+ unresectable LA/mBC for up to 8 years. Diagnosis of unresectable LA or mBC can be up to 6 months old prior to registry enrollment. Enrolled participants will receive treatment and clinical assessments for their HER2+ unresectable LA/mBC as determined by their treating physician, according to the standard of care and routine clinical practice at each site. Primary outcome measures are progression-free survival per anti-cancer treatment regimens assessed according to site-/country-specific medical practice and percentage of participants by different anti-cancer treatment regimens and treatment sequences. Secondary outcome measures include overall survival, duration of response per anti-cancer treatment regimens, percentage of participants with best overall response of complete response or partial response per anti-cancer treatment and total number of treatment regimens received by participants.
Clinical trial identification
NCT02913456, EUPAS22426, MO39146.
Legal entity responsible for the study
F. Hoffmann-La Roche Ltd.
F. Hoffmann-La Roche Ltd.
G.G. Steger: Honoraria and travel support: Roche Austria. F. Puglisi: Compensation for an advisory board: Roche. C. Timcheva: Travel support: Roche Bulgaria. L. Costa: Honoraria and travel support: Roche Portugal. D. Hitzl: Employee: Roche Austria. B. Dampier: Fees for services: Roche Austria. N. Lindegger: Employee: F.Hoffmann-La Roche. All other authors have declared no conflicts of interest.