Status:
COMPLETED
Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer
Lead Sponsor:
Daehwa Pharmaceutical Co., Ltd.
Conditions:
Recurrent or Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 M...
Eligibility Criteria
Inclusion
- Key
- 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).
- Key
Exclusion
- 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).
Key Trial Info
Start Date :
July 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2022
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03326102
Start Date
July 6 2018
End Date
December 13 2022
Last Update
February 16 2024
Active Locations (15)
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1
California Research Institute (CRI)
Los Angeles, California, United States, 90027
2
University of California San Francisco (UCSF)
San Francisco, California, United States, 94115
3
Boca Raton Regional Hospital (BRRH)
Boca Raton, Florida, United States, 33486
4
ASCLEPES Research Center(ARC)
Weeki Wachee, Florida, United States, 34607