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Brief Title: An Extension Study to Provide Oraxol to Patients Who Completed KX-ORAX-007
Official Title: An Extension Study to Provide Oraxol to Patients Who Completed KX-ORAX-007
Study ID: NCT04168957
Brief Summary: KX-ORAX-008 is an extension study of patients who completed KX-ORAX-007 without disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and who wish to continue Oraxol treatment.
Detailed Description: This is a multicenter, open-label, extension study offering the option of further Oraxol treatment to breast cancer patients who have completed the KX-ORAX-007 Oraxol study with complete response (CR), partial response (PR), or stable disease (SD), and who wish to continue further Oraxol treatment. The study contains 3 periods: the Screening Period, the Treatment Period, and the Follow-up Period. A Final Visit will occur within 7 days of the last dose of study treatment.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Taipei Medical University Shuang Ho Hospital, New Taipei City, , Taiwan
China Medical University Hospital, Taichung city, , Taiwan
Taipei Veterans Generla Hospital, Taipei, Taiwan, 11217, , Taiwan
Taipei Medical University Hospital, Taipei, , Taiwan
Tr-Service General Hospital, Taipei, , Taiwan
Name: David Cutler, MD
Affiliation: Athenex, Inc.
Role: STUDY_DIRECTOR