Status:
ACTIVE_NOT_RECRUITING
Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy
Lead Sponsor:
Daehwa Pharmaceutical Co., Ltd.
Conditions:
Recurrent or Metastatic Breast Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE2
PHASE3
Brief Summary
To compare and evaluate the efficacy and safety of Liporaxel® solution (oral paclitaxel) and Taxol® (IV paclitaxel) on recurrent or metastatic breast cancer.
Eligibility Criteria
Inclusion
- Key inclusion/exclusion criteria
- Histologically or cytologically confirmed to have recurrent, or metastatic breast cancer.
- Measurable disease (revised RECIST, version 1.1).
- Hormone receptor (ER/PR) positive or negative, HER2 negative.
- Subjects were eligible for the study regardless of their previous lines of endocrine therapy.
- No prior chemotherapy is allowed in metastatic disease.
- Subjects who administrated the last dose of taxane class drug ≥12months ago as from the first administration day.
- ECOG performance status ≤1.
- Neuropathy grade \<2.
- Subjects with central nervous system metastasis should be excluded.
Exclusion
Key Trial Info
Start Date :
December 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
549 Patients enrolled
Trial Details
Trial ID
NCT03315364
Start Date
December 18 2017
End Date
December 31 2025
Last Update
July 25 2024
Active Locations (51)
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1
Oncology Complex Center - Burgas'' Ltd., Medical Oncology Department
Burgas, Bulgaria, 8000
2
Multi-profile Hospital for Active Treatment Uni Hospital Ltd. Medical Oncology Department
Panagyurishte, Bulgaria, 4500
3
Medical Center Nadezhda Clinical" Ltd.,
Sofia, Bulgaria, 1330
4
Anhui Cancer Hospital
Hefei, Anhui, China