Actively Recruiting
A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients
Led by Jina Pharmaceuticals Inc. · Updated on 2025-03-21
657
Participants Needed
4
Research Sites
390 weeks
Total Duration
On this page
Sponsors
J
Jina Pharmaceuticals Inc.
Lead Sponsor
I
Intas Pharmaceuticals, Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 65 years
- Patients willing to sign informed consent to participate in the study
- Histopathologically or cytologically confirmed triple-negative breast cancer
- Patients may have had one prior chemotherapy regimen for adjuvant therapy and/or one chemotherapy regimen for first-line metastatic therapy
- Patients have locally advanced or metastatic breast cancer after failure of prior chemotherapy
- At least one measurable lesion as per RECIST criteria version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Left Ventricular Ejection Fraction (LVEF) of 50% or higher measured by echocardiography
- Recovery from toxic effects of previous chemotherapy or radiotherapy as judged by the Investigator
- Completed any previous chemotherapy or radiotherapy at least 4 weeks prior to starting study drug
- Life expectancy of at least 6 months
- Negative serum pregnancy test at screening and urine pregnancy test on Day 1 before randomization
- Sexually active women, unless surgically sterile or postmenopausal for at least 12 months, must use effective contraception from 4 weeks before, during, and for 30 days after last dose of study drug
- Adequate bone marrow, kidney, and liver function
You will not qualify if you...
- History of hypersensitivity to Docetaxel, any formulation components, or drugs with polysorbate 80
- History of HER2 positive overexpression or hormone receptor positive (ER or PR) breast cancer
- Prior exposure to Docetaxel injection in metastatic setting
- Cardiac conditions including unstable angina, myocardial infarction within past 6 months, severe uncontrolled ventricular arrhythmias, significant pericardial disease, acute ischemia on ECG, abnormal cardiac conduction unless stable for 6 months, or NYHA class 2 or higher heart disease
- Uncontrolled diabetes or infection
- History of drug addiction within past year
- Known central nervous system lesions except asymptomatic brain metastases
- Participation in other drug research or receipt of investigational medicinal product within 30 days prior to study drug
- Pre-existing motor or sensory neuropathy of grade 2 or higher by NCI CTCAE 4.03 criteria
- Known HIV infection
- Any other condition that may increase risk or affect study data as judged by the Investigator
- Unwillingness or inability to follow study protocol requirements
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Columbus Regional Research Institute, LLC
Columbus, Georgia, United States, 31904
Actively Recruiting
2
Cox Medical Center
Springfield, Missouri, United States, 65807
Actively Recruiting
3
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Actively Recruiting
4
Kailash Cancer Hospital & Research Centre
Vadodara, Gujarat, India, 391760
Actively Recruiting
Research Team
M
Mr. Prashant Modi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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