Overview

This trial has been completed.

Condition breast cancer nos metastatic recurrent
Treatments nk105, paclitaxel
Phase phase 3
Sponsor Nippon Kayaku Co.,Ltd.
Start date July 2012
End date July 2016
Trial size 436 participants
Trial identifier NCT01644890, A3105301

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
nk105
IV, Weekly
(Active Comparator)
paclitaxel
IV, Weekly

Primary Outcomes

Measure
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 February 2017.
Information provided to ClinicalTrials.gov by Nippon Kayaku Co.,Ltd..