A Phase III Study of NK105 in Patients With Breast Cancer
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To verify the non-inferiority of NK105, a paclitaxel-incorporating micellar nanoparticle, to paclitaxel in terms of the progression-free survival in patients with metastatic or recurrent breast cancer.
Condition or disease
Breast Cancer Nos Metastatic Recurrent
Drug: NK105Drug: Paclitaxel
This study is a randomized, open-label, multi-national phase III study.
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Layout table for eligibility information
Ages Eligible for Study:
20 Years to 74 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
Prior systemic chemotherapy with taxane anticancer drugs for metastatic or recurrent breast cancer.