Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Phase III Open-label Study of the Efficacy and Safety of Trastuzumab MCC-DM1 vs. Capecitabine + Lapatinib in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy
Brief Summary: This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer. 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.


Options:
A: Number of Participants Experiencing Adverse Events (AEs) (Serious AEs: Up to 90 days after last dose of treatment (Up to 28 months); nonserious AEs: Up to 30 days after last dose of treatment (Up to 26 months) - through final analysis (FA) cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C)); Number of Participants Discontinuing From Study Treatment Due to an AE (Up to last dose of study treatment (Up to approximately 25 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C)); Overall Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Response Rate Based on Blinded Independent Central Radiology (BICR) Review (Cohorts A, B, C, and D) (Every 8 weeks until disease progression (Cohorts A, B, D: Up to ~ 35 months; Cohort C: Up to ~ 28 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, D) & 01 Sep 2015 (Cohort C)); Overall RECIST 1.1 Response Rate Based on BICR Review for Participants in Cohort B2 (Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016)
B: Overall Survival (OS) (2.5 years)
C: Overall Survival Time (OS) (Randomization up to 27.5 months)
D: Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC) (From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)); Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint) (From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)); Percentage of Participants Who Died: Second Interim Analysis (From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)); Overall Survival: Second Interim Analysis (Co-primary Endpoint) (From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)); Percentage of Participants Who Died: Final Analysis (From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)); Overall Survival: Final Analysis (From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)); Percentage of Participants Who Were Alive at Year 1 (Year 1); Percentage of Participants Who Were Alive at Year 2 (Year 2)

Answer: D