Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy

[Phase II] Progression Free Survival (PFS)

Progression Free Survival (PFS) is defined as the time from date of randomization until the date of first documented progression or death

Time frame: From date of randomization, assessed up to 18 months.

[Phase III] Objective Response Rate (ORR)

Objective Response Rate (ORR) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria.

Time frame: Participants will be followed every 6 weeks until progression, an expected average of 9 months.

[Phase II&III] Overall Survival(OS)

Overall survival(OS) is defined as the time from the date of inclusion to the date of death, regardless of the cause of death.

Time frame: Until 6 months after the last participant is enrolled, assessed minimum to 18 months.

[Phase II&III] Time to Treatment Failure(TTF)

TTF is defined as the time from the randomization date to the date of discontinuation of treatment, regardless of the cause.

Time frame: through study completion, an expected average of 4.5 year.