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

NCT03671044 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 657

Last updated 2025-03-21

No results posted yet for this study

Summary

The Nanosomal Docetaxel Lipid Suspension (NDLS) consists of uniformly sized micro particles of docetaxel suspended in a lipid based formulation. The advantage of such a Lipid Based formulation of Docetaxel is an improvement of the safety profile by eliminating excipients, polysorbate 80 and ethanol which are present in conventional Docetaxel formulations (Taxotere®). This randomized, open-label study is designed to assess the efficacy and safety of Nanosomal Docetaxel Lipid Suspension at the dose of 75 mg/m2 and at the dose of 100 mg/m2 compared to Taxotere® at the dose of 100 mg/m2 in triple-negative breast cancer patients with Locally Advanced or Metastatic Breast Cancer. Patients will continue the treatment in the absence of disease progression and unacceptable toxicity. Disease status and tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines. 657 patients (219 patients per arm) will be randomized in the study. The trial will be conducted as per the ICH GCP Guidelines E6 (R1), Schedule Y (Amended Version 2013), Declaration of Helsinki (Fortaleza, Brazil, October 2013), ICMR Guidelines for Biomedical Research on Human subjects and in accordance with other applicable guidelines.

Conditions

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

Sponsors & Collaborators

  • Intas Pharmaceuticals, Ltd.

    collaborator INDUSTRY

  • Lambda Therapeutic Research Ltd.

    collaborator INDUSTRY

  • Jina Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Dr. Ravi Alamchandani · Lambda Therapeutic Research Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-10
Primary Completion
2025-05-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States
  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03671044 on ClinicalTrials.gov