A Phase III Study of NK105 in Patients With Breast Cancer

Study Overview
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Brief Summary
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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.

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

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

Conditions
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Breast Cancer Nos Metastatic Recurrent

Intervention / Treatment
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* Drug: NK105
* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NK105<br> | Drug: NK105<br>* IV, Weekly<br>|
| Active Comparator: Paclitaxel<br> | Drug: Paclitaxel<br>* IV, Weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NK105, Paclitaxel, Breast cancer, Micelle