A Phase III Study of NK105 in Patients With Breast Cancer

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nippon Kayaku Co., Ltd.; Nippon Kayaku Co.,Ltd.
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

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.