This trial is active, not recruiting.

Condition breast cancer nos metastatic recurrent
Treatments nk105, paclitaxel
Phase phase 3
Sponsor Nippon Kayaku Co.,Ltd.
Start date July 2012
End date December 2017
Trial size 414 participants
Trial identifier NCT01644890, A3105301


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
IV, Weekly
(Active Comparator)
IV, Weekly

Primary Outcomes

Progression free survival
time frame: 4.2 years

Eligibility Criteria

Female participants from 20 years up to 74 years old.

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.

Additional Information

Official title A Multi-national Phase III Clinical Study Comparing NK105 Versus Paclitaxel in Patients With Metastatic or Recurrent Breast Cancer
Description This study is a randomized, open-label, multi-national phase III study.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Nippon Kayaku Co.,Ltd..