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Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer

Trial Status: Active

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of DHP107 (Oral Paclitaxel, Korea brand name: Liporaxel®) compared to IV Paclitaxel in patients with Recurrent or Metastatic Breast Cancer.

Inclusion Criteria

  • Subjects with confirmed diagnosis of recurrent or metastatic breast cancer based on histopathology examination
  • Subjects with diagnosis of HER2-negative breast cancer that was confirmed by IHC or in situ hybridization (ISH) assessment of tumor samples
  • Subjects who have received up to 3 lines of therapy for advanced disease, without prior exposure to taxane in the advanced stage setting
  • Subjects who have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Subjects who have measurable disease according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1).

Exclusion Criteria

  • Subjects who have received prior taxane therapy in the metastatic setting
  • Subjects whose adjuvant or neoadjuvant treatment for early stage breast cancer was completed within 6 months prior to entry into the study.
  • Subjects with neuropathy grade ≥2 based on CTCAE v4.03 at the time of study entry
  • Subjects with symptomatic, untreated metastases to the central nervous system (CNS) at the time of screening.
  • Subjects who have received any investigational drugs or devices within 4 weeks before the first day of study treatment (C1D1).

California

San Francisco
UCSF Medical Center-Mount Zion
Status: ACTIVE
Contact: Hope S. Rugo
Phone: 415-353-7070

Kansas

Fairway
University of Kansas Clinical Research Center
Status: ACTIVE
Kansas City
University of Kansas Cancer Center
Status: ACTIVE
University of Kansas Cancer Center-West
Status: ACTIVE
Overland Park
University of Kansas Cancer Center-Overland Park
Status: ACTIVE
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: ACTIVE

Missouri

Kansas City
University of Kansas Cancer Center - North
Status: ACTIVE
Lee's Summit
University of Kansas Cancer Center - Lee's Summit
Status: ACTIVE

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: COMPLETED

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Daehwa Pharmaceutical Co., Ltd.

  • Primary ID 107CS-6
  • Secondary IDs NCI-2018-01373
  • Clinicaltrials.gov ID NCT03326102