Spots Global Cancer Trial Database for An Extension Study to Provide Oraxol to Patients Who Completed KX-ORAX-007

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Trial Identification

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

Conditions

Breastcancer

Interventions

Oraxol

Study Description

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.