A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients

PHASE3RecruitingINTERVENTIONAL
Enrollment

657

Participants

Timeline

Start Date

July 10, 2018

Primary Completion Date

May 31, 2025

Study Completion Date

December 31, 2025

Conditions
Triple Negative Breast Cancer
Interventions
DRUG

Nanosomal Docetaxel Lipid Suspension (75 mg/m2)

Each vial containing lyophilized Docetaxel lipid powder, equivalent to 20 mg or 80 mg of anhydrous Docetaxel.

DRUG

Nanosomal Docetaxel Lipid Suspension (100 mg/m2)

Each vial containing lyophilized Docetaxel lipid powder, equivalent to 20 mg or 80 mg of anhydrous Docetaxel.

DRUG

Taxotere® (100 mg/m2)

Docetaxel Injection Concentrate; 20 mg/0.5 mL

Trial Locations (4)

31904

RECRUITING

Columbus Regional Research Institute, LLC, Columbus

44718

RECRUITING

Gabrail Cancer Center, Canton

65807

RECRUITING

Cox Medical Center, Springfield

391760

RECRUITING

Kailash Cancer Hospital & Research Centre, Vadodara

All Listed Sponsors
collaborator

Intas Pharmaceuticals, Ltd.

INDUSTRY

collaborator

Lambda Therapeutic Research Ltd.

INDUSTRY

lead

Jina Pharmaceuticals Inc.

INDUSTRY