A Phase III Study of NK105 in Patients With Breast Cancer
NCT ID: NCT01644890
Last Updated: 2019-07-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
436 participants
INTERVENTIONAL
2012-07-31
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NK105
NK105
IV, Weekly
Paclitaxel
Paclitaxel
IV, Weekly
Interventions
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NK105
IV, Weekly
Paclitaxel
IV, Weekly
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed metastatic or recurrent adenocarcinoma of the breast.
* Aged 20 to 74 at the time of informed consent.
Exclusion Criteria
20 Years
74 Years
FEMALE
No
Sponsors
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Nippon Kayaku Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Call +81-3-6731-5200 Mon - Fri 9 AM - 5 PM (Japan Time)
Role: STUDY_DIRECTOR
Nippon Kayaku Co., Ltd.
Locations
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Japan Sites
Tokyo, Etc., , Japan
Countries
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References
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Fujiwara Y, Mukai H, Saeki T, Ro J, Lin YC, Nagai SE, Lee KS, Watanabe J, Ohtani S, Kim SB, Kuroi K, Tsugawa K, Tokuda Y, Iwata H, Park YH, Yang Y, Nambu Y. A multi-national, randomised, open-label, parallel, phase III non-inferiority study comparing NK105 and paclitaxel in metastatic or recurrent breast cancer patients. Br J Cancer. 2019 Mar;120(5):475-480. doi: 10.1038/s41416-019-0391-z. Epub 2019 Feb 12.
Other Identifiers
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A3105301
Identifier Type: -
Identifier Source: org_study_id
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