Emilia trial

All other lesions or sites of disease should be identified as non-TLs and recorded at baseline. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs on the basis of their size and their suitability for accurate repeated measurements either by imaging or clinically and recorded at baseline.

All other lesions were identified as non-TLs and recorded at baseline. Percentage of Participants Who Died: Second Interim Analysis [ Time Frame: From the date of randomization through the data cut-off date of 31 Jul up to 3 years, 5 months ] The percentage of participants who died from any cause was reported.

The results are reported from second interim analysis, which deemed to be the confirmatory. Overall Survival: Second Interim Analysis Co-primary Endpoint [ Time Frame: From the date of randomization through the data cut-off date of 31 Jul up to 3 years, 5 months ] OS was defined as the time from the date of randomization to the date of death from any cause.

The median duration of OS was estimated using Kaplan-Meier method. Percentage of Participants Who Died: Final Analysis [ Time Frame: From the date of randomization through the data cut-off date of 31 Dec up to 5 years, 11 months ] The percentage of participants who died from any cause was reported. The results reported are from the final analysis. The final analysis is descriptive.

Overall Survival: Final Analysis [ Time Frame: From the date of randomization through the data cut-off date of 31 Dec up to 5 years, 11 months ] OS was defined as the time from the date of randomization to the date of death from any cause.

Percentage of Participants Who Were Alive at Year 1 [ Time Frame: Year 1 ] 1 year survival was defined as the percentage of participants alive 1 year after starting treatment. Percentage of Participants Who Were Alive at Year 2 [ Time Frame: Year 2 ] 2 year survival was defined as the percentage of participants alive 2 years after starting treatment. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline.

The percentage of participants who died or experienced PD by Investigator was reported. PFS was defined as the time from randomization to first documented PD by Investigator or death from any cause whichever occurred earlier.

Confirmation of response at a consecutive tumor assessment at least 4 weeks apart was required. Participants without a post-baseline tumor assessment were considered non-responders. DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier. Participants were considered as experienced clinical benefit if they had an OR or maintained stable disease SD for at least 6 months from randomization. Percentage of Participants With Treatment Failure [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan up to 2 years, 11 months ] Treatment failure was defined as discontinuation of treatment for any reason, including PD per investigator review , treatment toxicity, or death from any cause.

Percentage of participants with treatment failure was reported. Time to Treatment Failure [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan up to 2 years, 11 months ] Time to treatment failure was defined as the time from randomization to discontinuation of treatment for any reason, including PD per investigator review , treatment toxicity, or death from any cause. The median time to treatment failure was estimated using Kaplan-Meier method.

All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 "not at all" to 4 "very much". The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The percentage of participants with symptom progression was reported. The median time to symptom progression was estimated using Kaplan-Meier method. Talk with your doctor and family members or friends about deciding to join a study.

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Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Results First Posted : April 23, Last Update Posted : October 31, Study Description. Participants will be treated until disease progression PD , unmanageable toxicity, or study termination. Once disease progression is reported, all participants will be followed for survival every 3 months until death, loss to follow-up, withdrawal of consent, or study termination.

MedlinePlus related topics: Breast Cancer. FDA Resources. Arms and Interventions. Trastuzumab emtansine 3. Lapatinib mg five mg tablets orally once daily during each day cycle.

On May 30, , the study protocol was amended to allow crossover from control to trastuzumab emtansine after the second interim overall survival analysis crossed the prespecified overall survival efficacy boundary.

This study is registered with ClinicalTrials. Nine patients died from adverse events; five of these deaths were judged to be related to treatment two in the control group [coronary artery disease and multiorgan failure] and three in the trastuzumab emtansine group [metabolic encephalopathy, neutropenic sepsis, and acute myeloid leukaemia].

Interpretation: This descriptive analysis of final overall survival in the EMILIA trial shows that trastuzumab emtansine improved overall survival in patients with previously treated HER2-positive metastatic breast cancer even in the presence of crossover treatment. The safety profile was similar to that reported in previous analyses, reaffirming trastuzumab emtansine as an efficacious and tolerable treatment in this patient population.

Abstract Background: The antibody-drug conjugate trastuzumab emtansine is indicated for the treatment of patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane.