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A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients
NCT03671044 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Nanosomal Docetaxel Lipid Suspension (75 mg/m2)
- DRUG Nanosomal Docetaxel Lipid Suspension (100 mg/m2)
- DRUG Taxotere® (100 mg/m2)
Study Locations (4)
Georgia
- Columbus Regional Research Institute, LLC — Columbus
Missouri
- Cox Medical Center — Springfield
Ohio
- Gabrail Cancer Center — Canton
Gujarat
- Kailash Cancer Hospital & Research Centre — Vadodara
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 657 participants |
| Start Date | 2018-07-10 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03671044
The ClinicalTrials.gov registry entry for NCT03671044 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 657 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jina Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which Nanosomal Docetaxel Lipid Suspension (75 mg/m2) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03671044 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Georgia, Missouri, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03671044 about?
NCT03671044 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients". 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 ...
What is the current status of trial NCT03671044?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 657 participants. The study started on 2018-07-10. Estimated completion is 2025-12-31.
What conditions does trial NCT03671044 study?
This clinical trial studies the following conditions: Triple Negative Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03671044?
The interventions under investigation include: Nanosomal Docetaxel Lipid Suspension (75 mg/m2) (DRUG), Nanosomal Docetaxel Lipid Suspension (100 mg/m2) (DRUG), Taxotere® (100 mg/m2) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03671044?
This trial is sponsored by Jina Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03671044 being conducted?
This trial has 4 study locations across Georgia, Missouri, Ohio, Gujarat. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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