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Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial.

Please complete the following multiple choice questions based on the EMILIA trial:

Question 1 of 15

Choose the correct answer(s) to complete the statementThe EMILIA trial, which was a randomised, international, open-label, phase 3 study was conducted in patients that were:

Question 2 of 15

Choose the correct answer(s): The total number of patients included in the EMILIA trial were

Question 3 of 15

Indicate which statement(s) are correct: Patients were randomly assigned (1:1) treatment of trastuzumab emtansine (3·6 mg/kg intravenously every 3 weeks) or control. The control in the EMILIA trial was:

Question 4 of 15

Choose which statement(s) are correct: Trastuzumab emtansine is _________________

Question 5 of 15

Choose the correct answer: Approval of trastuzumab emtansine was based on the phase 3 EMILIA study, which showed that in patients with HER2-positive advanced breast cancer previously treated with trastuzumab and a taxane, trastuzumab emtansine:

Question 6 of 15

Indicate whether this statement is True or False: The coprimary efficacy endpoints were progression-free survival (per independent review committee assessment) and overall survival.

Question 7 of 15

Which one of the following answers is correct?In the primary progression-free survival analysis of EMILIA, median progression-free survival was _________ months in the trastuzumab emtansine group and _________ months in the capecitabine plus lapatinib group (hazard ratio [HR] 0·65 [95% CI 0·55–0·77]; p<0·0001)

Question 8 of 15

Indicate which of the following statements is correct pertaining to the second (confirmatory) interim overall survival analysis of EMILIA.The median overall survival (HR 0·68 [95% CI 0·55–0·85]; p<0·001) for trastuzumab emtansine was _______ (____ months) as/than capecitabine plus lapatinib (25·1 months)

Question 9 of 15

Indicate whether this statement is True or False: After the improved overall survival observed with trastuzumab emtansine was confirmed during the second interim overall survival analysis, the study protocol was amended to allow crossover from the control group (capecitabine plus lapatinib) to the trastuzumab emtansine group, regardless of whether they still met the study’s original eligibility criteria

Question 10 of 15

Select the correct answer: The percentage of the 496 patients that crossed over from control to trastuzumab emtansine after the second interim overall survival analysis (median follow-up duration 24·1 months [IQR 19·5–26·1]), was ______ %

Question 11 of 15

Choose the correct answer for the following statement: In the final analysis, median overall survival with trastuzumab emtansine was ________ ( months) than with control (25.9 months [95% CI 22·7–28·3]; hazard ratio 0·75 [95% CI 0·64–0·88])

Question 12 of 15

Choose the correct answer for the statement:Safety was analysed in all patients who received ______________

Question 13 of 15

Which one statement is correct?

Question 14 of 15

Indicate whether the statement is True or False: The safety profile of trastuzumab emtansine was similar to that reported previously

Question 15 of 15

When comparing the results of trastuzumab emtansine versus capecitabine plus lapatinib in the phase 3 EMILIA trial, the following statements are relevant: