Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Recurrence

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

NK105

Call +81-3-6731-5200 Mon - Fri 9 AM - 5 PM (Japan Time)

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.

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

A Phase III Study of NK105 in Patients With Breast Cancer

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

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

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

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

Nippon Kayaku Co., Ltd.

received NK105 (65 mg/m\^2) on days 1, 8 and 15 of a 28-day cycle

received Paclitaxel (80 mg/m\^2) on days 1, 8 and 15 of a 28-day cycle

Total

Age, Continuous

Sex: Female, Male

Japan

South Korea

Taiwan

Region of Enrollment

All randomized patients who received study drug at least once

Pharmaceuticals Group

Based on the results of previous studies, the expected median PFS was 5.5 months for PTX and 6.35 months for NK105. Assuming a randomization period of 18 months, a follow-up period of 12 months, a one-sided significance level of 2.5%, a power of 85% and the non-inferiority margin of 1.215, the number of patients was estimated to 172 pts per group, a total of 344 patients. Considering an expected withdrawal/dropout rate of approximately 20%, the target sample size was set at 414.

All randomized patients who received study drug at least once and who had no major violations of the eligiblity criteria

Progression Free Survival

History of chemotherapy for metastatic or recurrent breast cancer (yes/no), History of treatment using a taxane anticancer drug (yes/no), ER status \[ER (+) or ER (-)\], and Disease free interval (\<12 months or ≥12 months) were covariates for adjustment.

Spots Global Cancer Trial Database for A Phase III Study of NK105 in Patients With Breast Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial