A Phase III Study of NK105 in Patients With Breast Cancer | NCT01644890

A Phase III Study of NK105 in Patients With Breast Cancer | NCT01644890 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
NK105	Experimental		Drug: NK105
Paclitaxel	Active Comparator		Drug: Paclitaxel

Name	Type	Description	Arm Group Labels	Other Names
NK105	Drug	IV, Weekly	NK105
Paclitaxel

Outcomes Module

Primary Outcomes

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 Outcomes

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

Contacts/Locations Module

Name	Affiliation	Role
Call +81-3-6731-5200 Mon - Fri 9 AM - 5 PM (Japan Time)	Nippon Kayaku Co., Ltd.	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30745582	Derived	Fujiwara Y, Mukai H, Saeki T, Ro J, Lin YC, Nagai SE, Lee KS, Watanabe J, Ohtani S, Kim SB, Kuroi K, Tsugawa K, Tokuda Y, Iwata H, Park YH, Yang Y, Nambu Y. A multi-national, randomised, open-label, parallel, phase III non-inferiority study comparing NK105 and paclitaxel in metastatic or recurrent breast cancer patients. Br J Cancer. 2019 Mar;120(5):475-480. doi: 10.1038/s41416-019-0391-z. Epub 2019 Feb 12.

ID	Title	Description
FG000	NK105	received NK105 (65 mg/m^2) on days 1, 8 and 15 of a 28-day cycle
FG001	Paclitaxel	received Paclitaxel (80 mg/m^2) on days 1, 8 and 15 of a 28-day cycle

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000218 subjects FG001218 subjects
COMPLETED		FG0002 subjects FG0013 subjects
NOT COMPLETED		FG000216 subjects FG001215 subjects

Type	Comment	Reasons
Adverse Event		FG0007 subjects FG00120 subjects
Death		FG0001 subjects FG001

Baseline Characteristics Module

ID	Title	Description
BG000	NK105	received NK105 (65 mg/m^2) on days 1, 8 and 15 of a 28-day cycle
BG001	Paclitaxel	received Paclitaxel (80 mg/m^2) on days 1, 8 and 15 of a 28-day cycle

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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

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

Posted

Median

95% Confidence Interval

months

Baseline, every 6 weeks of study treatment period, and end of study,

ID	Title	Description
OG000	NK105	received NK105 (65 mg/m^2) on days 1, 8 and 15 of a 28-day cycle
OG001	Paclitaxel

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	NK105	received NK105 (65 mg/m^2) on days 1, 8 and 15 of a 28-day cycle	3

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Leukocytosis	Blood and lymphatic system disorders	MedDRA Ver.19.0	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Ver.19.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Pharmaceuticals Group	Nippon Kayaku Co., Ltd.	+81-3-6731-5200

Condition Browse Module

ID	Term
D001943	Breast Neoplasms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Intervention Browse Module

ID	Term
C500671	NK105
D017239	Paclitaxel

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

Region of Enrollment

Number

participants

Title

Denominators

Categories

Japan

Title	Measurements
	BG000136 BG001143 BG002279

South Korea

Title	Measurements
	BG00051 BG00142 BG00293

Taiwan

Title	Measurements
	BG00027 BG00128 BG00255

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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.					Hazard Ratio (HR)	1.255			2-Sided	95	0.989	1.592			History of chemotherapy for metastatic or recurrent breast cancer (yes/no), History of treatment using a taxane anticancer drug (yes/no), ER status [(+) or (-)], and Disease free interval (<12 months or ≥12 months) were covariates for adjustment.		Non-Inferiority	The primary PFS analysis was confirmed whether or not the upper limit of the 95% confidence interval (CI) for the hazard ratio (HR) for NK105 relative to PTX fell below the non-inferiority margin of 1.215 (<1.215) by fitting a Cox proportional hazards model that included allocation adjustment factors other than the study site as covariates.

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

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.

Posted

Median

95% Confidence Interval

months

Baseline, every 6 weeks of study treatment period, and end of study.

ID	Title	Description
OG000	NK105	received NK105 (65 mg/m^2) on days 1, 8 and 15 of a 28-day cycle
OG001	Paclitaxel	received Paclitaxel (80 mg/m^2) on days 1, 8 and 15 of a 28-day cycle

Units	Counts
Participants	OG000211 OG001211

Title

Denominators