A Phase III Study of NK105 in Patients With Breast Cancer

Breast Cancer Nos Metastatic Recurrent Clinical Trial

Official title:

A Multi-national Phase III Clinical Study Comparing NK105 Versus Paclitaxel in Patients With Metastatic or Recurrent Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644890
• Other study ID #: A3105301
• Status: Completed
• Phase: Phase 3
• Start date: July 2012
• Est. completion date: January 2017

Study information

• Verified date: February 2016
• Source: Nippon Kayaku Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study is a randomized, open-label, multi-national phase III study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• Est. completion date: January 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Nos Metastatic Recurrent
• Breast Neoplasms

Intervention

Drug:
• NK105
IV, Weekly
• Paclitaxel
IV, Weekly

Locations

Country	Name	City	State
Japan	Japan Sites	Tokyo, Etc.

Sponsors (1)

Lead Sponsor	Collaborator
Nippon Kayaku Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	PFS is defined as the period from the day of randomization until the first observation of lesion progression or death from any cause. Disease progression is defined as PD according to RECIST Ver. 1.1.; Assessment period was from the day of randomisation until the first observation of lesion progression or death	Baseline, every 6 weeks of study treatment period, and end of study,
Secondary	Overall Survival	OS is defined as the period from the day of randomization until the day of death from any cause.; Assessment period was from the day of randomisation until the first observation of lesion progression or death	Baseline, every 6 weeks of study treatment period, and end of study.
Secondary	Overall Response Rate	ORR is the proportion of patients who are assessed as complete response or partial response as the best overall response among evaluable patients, according to RECIST Ver.1.1.; Assessment period was from the day of randomisation until the first observation of lesion progression or death	Baseline, every 6 weeks of study treatment period, and end of study.