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Brief Title: A PK Study of Oraxol in Breast Cancer Patients
Official Title: A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients
Study ID: NCT04993040
Brief Summary: This is a multicenter, open-label, single-arm PK study in approximately 24 breast cancer patients for whom paclitaxel treatment is indicated.
Detailed Description: This is a multicenter, open-label, single-arm PK study in approximately 24 breast cancer patients for whom paclitaxel treatment is indicated. The study contains 3 periods: the Screening / Baseline Period, the Treatment Period, and the Follow-up Period. A Final Visit will occur within 7 days of the last dose of study treatment. If subjects achieve stable disease (SD), partial response (PR), or complete response (CR) at the end of the Treatment Period, they may continue Oraxol treatment in a separate extension study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China
Name: Erwei Song, Pro.f
Affiliation: Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR
Name: Herui Yao, Pro.f
Affiliation: Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR