Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03671044 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients
A Phase 3 study of Triple Negative Breast Cancer, sponsored by Jina Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 657
- Enrollment target
- 4
- Study locations
NCT03671044: Recruiting Phase 3 study of Triple Negative Breast Cancer, sponsored by Jina Pharmaceuticals.
NCT03671044 is a Phase 3 study of Triple Negative Breast Cancer that is actively recruiting participants, run by Jina Pharmaceuticals. The registered enrollment target is 657 participants, above the 241-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (173% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03671044, a Phase 3 study of Triple Negative Breast Cancer, is actively recruiting participants, sponsored by Jina Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 657 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
Non-inferiority of NDLS (75 mg/m2, 100 mg/m2) compared to Taxotere (100 mg/m2)
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 |
What NCT03671044 shows while recruiting
NCT03671044 is an interventional study that assigns participants to a tested intervention. The registered 657 participants enrollment target is mid-sized for trials with a published cap, above the 241-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (173% higher).
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.
NCT03671044 reports a single indexed study location in Georgia, Missouri, Ohio.
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.
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).
Who is sponsoring clinical trial NCT03671044?
This trial is sponsored by Jina Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Triple Negative Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03671044's enrollment target sits among peer trials
657 12th of 118 higher than 107 of 118 other Triple Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Triple Negative Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)
RECRUITING · Phase 3
-
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
RECRUITING · Phase 3
-
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer
ACTIVE NOT RECRUITING · Phase 3
-
Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC
ACTIVE NOT RECRUITING · Phase 3
-
Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo
ACTIVE NOT RECRUITING · Phase 3
-
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05338697 · 657 participants
Validation of Early Prognostic Data for Recovery Outcome After Stroke for Future, Higher Yield Trials
- NCT05407129 · 656 participants · NA
Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences
- NCT06127199 · 656 participants · NA
Contraceptive Efficacy Study of Ovaprene
- NCT07216742 · 659 participants · Phase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI