biostudies-literatureUnknown4Wang X<h4>Background</h4>The antibody-drug conjugate (ADCs) trastuzumab emtansine (T-DM1) is approved for human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (mBC) previously treated with trastuzumab and a taxane. The phase III ELAINA trial aimed to determine the clinical utility of T-DM1 in Chinese patients.<h4>Methods</h4>ELAINA was a randomized, multicenter, open-label bridging study of Chinese patients with HER2-positive locally advanced breast cancer (LABC) or mBC previously treated with trastuzumab and a taxane. Using an interactive voice/internet response system, patients were randomized 3:1 to receive T-DM1 or lapatinib plus capecitabine. Patents were stratified by number of prior therapies in this disease setting and by presence of visceral disease using a permuted block randomization scheme. Patients received treatment until disease progression, unmanageable toxicity, or study termination. After that, data on survival and subsequent cancer therapies were collected at approximately 3-month intervals. The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints were overall response rate, duration of response, overall survival (OS), safety, patient-reported quality of life, and pharmacokinetics (PKs).<h4>Results</h4>ELAINA was fully enrolled with 200 patients randomized to T-DM1 (n=151) or lapatinib plus capecitabine (n=49). Median treatment duration was approximately 6 months in each study arm. Median follow-up time was approximately 9 months for all analyses except for OS. T-DM1 was associated with a 15% reduction in risk of disease progression or death compared with lapatinib plus capecitabine [stratified hazard ratio (HR) =0.85; 95% confidence interval (CI): 0.56-1.29] in the intent-to-treat (ITT) population. The objective response rate (ORR) was similar with T-DM1 (50.4%) and lapatinib plus capecitabine (55.8%); median duration of response was 8.4 months for both treatments. At a median follow-up time of approximately 30 months, OS was similar in each treatment arm. Incidence of grade ≥3 adverse events (AEs) was similar with T-DM1 (54.3%) and lapatinib plus capecitabine (57.1%). Grade ≥3 thrombocytopenia was greater with T-DM1 (40.4%) than with lapatinib plus capecitabine (4.1%); there was no grade ≥3 hemorrhage with either treatment.<h4>Conclusions</h4>T-DM1 demonstrated an acceptable benefit-risk profile in Chinese patients with HER2-positive LABC/mBC previously treated with trastuzumab and a taxane. T-DM1 therefore provides a chemotherapy-free option in this setting.<h4>Trial registration</h4>ClinicalTrials.gov identifier: NCT03084939.Translational breast cancer research : a journal focusing on translational research in breast cancer3https://www.ebi.ac.uk/biostudies/studies/S-EPMC11093095biostudies-literaturePrimary results of ELAINA: a randomized, multicenter, open-label, phase III study of the efficacy and safety of trastuzumab emtansine <i>vs.</i> lapatinib plus capecitabine in Chinese patients with HER2-positive locally advanced or metastatic breast cancer who have received prior trastuzumab-based therapy.PMC11093095Yin YLi HYang JTong ZWu FZhang QLi WRestuccia EJiang ZZheng HLamour FShao ZFeng JWang XfalsePrimary results of ELAINA: a randomized, multicenter, open-label, phase III study of the efficacy and safety of trastuzumab emtansine <i>vs.</i> lapatinib plus capecitabine in Chinese patients with HER2-positive locally advanced or metastatic breast cancer who have received prior trastuzumab-based therapy.<h4>Background</h4>The antibody-drug conjugate (ADCs) trastuzumab emtansine (T-DM1) is approved for human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (mBC) previously treated with trastuzumab and a taxane. The phase III ELAINA trial aimed to determine the clinical utility of T-DM1 in Chinese patients.<h4>Methods</h4>ELAINA was a randomized, multicenter, open-label bridging study of Chinese patients with HER2-positive locally advanced breast cancer (LABC) or mBC previously treated with trastuzumab and a taxane. Using an interactive voice/internet response system, patients were randomized 3:1 to receive T-DM1 or lapatinib plus capecitabine. Patents were stratified by number of prior therapies in this disease setting and by presence of visceral disease using a permuted block randomization scheme. Patients received treatment until disease progression, unmanageable toxicity, or study termination. After that, data on survival and subsequent cancer therapies were collected at approximately 3-month intervals. The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints were overall response rate, duration of response, overall survival (OS), safety, patient-reported quality of life, and pharmacokinetics (PKs).<h4>Results</h4>ELAINA was fully enrolled with 200 patients randomized to T-DM1 (n=151) or lapatinib plus capecitabine (n=49). Median treatment duration was approximately 6 months in each study arm. Median follow-up time was approximately 9 months for all analyses except for OS. T-DM1 was associated with a 15% reduction in risk of disease progression or death compared with lapatinib plus capecitabine [stratified hazard ratio (HR) =0.85; 95% confidence interval (CI): 0.56-1.29] in the intent-to-treat (ITT) population. The objective response rate (ORR) was similar with T-DM1 (50.4%) and lapatinib plus capecitabine (55.8%); median duration of response was 8.4 months for both treatments. At a median follow-up time of approximately 30 months, OS was similar in each treatment arm. Incidence of grade ≥3 adverse events (AEs) was similar with T-DM1 (54.3%) and lapatinib plus capecitabine (57.1%). Grade ≥3 thrombocytopenia was greater with T-DM1 (40.4%) than with lapatinib plus capecitabine (4.1%); there was no grade ≥3 hemorrhage with either treatment.<h4>Conclusions</h4>T-DM1 demonstrated an acceptable benefit-risk profile in Chinese patients with HER2-positive LABC/mBC previously treated with trastuzumab and a taxane. T-DM1 therefore provides a chemotherapy-free option in this setting.<h4>Trial registration</h4>ClinicalTrials.gov identifier: NCT03084939.2023-01-01T00:00:00Z20232026-06-01T17:31:38.212Z2026-04-08T14:22:22.367ZS-EPMC110930953875148810.21037/tbcr-23-2