Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Phase III Randomized Trial Comparing Doxorubicin and Cyclophosphamide Followed By Docetaxel (AC-T) With Doxorubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab (Herceptin)(AC-TH) and With Docetaxel, Carboplatin and Trastuzumab (TCH) In The Adjuvant Treatment Of Node Positive and High Risk Node Negative Patients With Operable Breast Cancer Containing The HER2 Alteration
Brief Summary: Primary objective:

* Compare disease-free survival in women with human epidermal growth factor receptor 2 (HER2)-neu-expressing node-positive or high-risk node-negative operable breast cancer treated with adjuvant doxorubicin, cyclophosphamide, and docetaxel with or without trastuzumab (Herceptin) vs trastuzumab, docetaxel, and carboplatin.

Secondary objective:

* Compare overall survival of participants treated with these regimens.
* Compare the toxic effects (including cardiac) of these regimens in these participants.
* Compare quality of life of participants treated with these regimens.
* Compare pathologic and molecular markers for predicting efficacy of these regimens in these participants.
* For substudy: Compare peripheral levels of shed HER2-neu extracellular domain with fluorescence in situ hybridization in predicting outcome in participants treated with these regimens.


Options:
A: Duration of DFS (Time from registration to first adverse event, assessed up to 15 years)
B: Percentage of Participants With Disease Free Survival at 5 Years (From randomization until relapse or death or up to 5 years)
C: Percentage of Participants With Disease-Free Survival (DFS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up (From Baseline until time of event (median of 1 year)); Percentage of Participants With DFS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up (From Baseline until time of event (median of 1 year)); DFS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up (Year 2); DFS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up (Year 2); Percentage of Participants With DFS Events Compared to Observation: 8-Year Median Follow-Up (From Baseline until time of event (median of 8 years)); DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up (Year 3); DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up (Year 5); DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up (Year 7); DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up (Year 8); Percentage of Participants With DFS Events Compared to Observation: 10-Year Maximum Follow-Up (From Baseline until time of event (maximum of 10 years)); DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up (Year 3); DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up (Year 5); DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up (Year 7); DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up (Year 8); DFS Rate at Year 9 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up (Year 9); DFS Rate at Year 10 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up (Year 10)
D: Disease Free Survival (DFS) (Time from randomization through 5 years); Cardiotoxicity (time from randomization through 4 months)

Answer: B