A Multi-national Phase III Clinical Study Comparing NK105 Versus Paclitaxel in Patients With Metastatic or Recurrent Breast Cancer
Phase 3
20 Years
74 Years
20 Years
74 Years
Open (Enrolling)
Female
Breast Cancer Nos Metastatic Recurrent
Female
Breast Cancer Nos Metastatic Recurrent
Trial Information
A Multi-national Phase III Clinical Study Comparing NK105 Versus Paclitaxel in Patients With Metastatic or Recurrent Breast Cancer
This study is a randomized, open-label, multi-national phase III study.
Inclusion Criteria:
- Written informed consent of the patient signed by herself.
- Histologically confirmed metastatic or recurrent adenocarcinoma of the breast.
- Aged 20 to 74 at the time of informed consent.
Exclusion Criteria:
- Prior systemic chemotherapy with taxane anticancer drugs for metastatic or recurrent
breast cancer.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression free survival
Outcome Time Frame:
2.5 years
Safety Issue:
No
Principal Investigator
Call +81-3-3237-5111 Mon - Fri 9 AM - 5 PM (Japan Time)
Investigator Role:
Study Director
Investigator Affiliation:
Nippon Kayaku Co.,Ltd.
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
A3105301
NCT ID:
NCT01644890
Start Date:
July 2012
Completion Date:
December 2014
Related Keywords:
- Breast Cancer Nos Metastatic Recurrent
- NK105, Paclitaxel, Breast cancer, Micelle
- Breast Neoplasms
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