Nanosomal Docetaxel for Triple Negative Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new formulation of a chemotherapy drug, Nanosomal Docetaxel Lipid Suspension (NDLS), to determine its effectiveness and safety for people with triple-negative breast cancer that has spread or is locally advanced. The study compares NDLS at two different doses with a standard treatment, Taxotere®, to identify which better controls the cancer. Individuals diagnosed with triple-negative breast cancer who have already tried ineffective chemotherapy might be suitable for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you must have recovered from any toxic effects of previous chemotherapy or radiotherapy, and these treatments should be completed 4 weeks before starting the trial medication.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that Nanosomal Docetaxel Lipid Suspension (NDLS) is generally easy for patients to handle in breast cancer treatments. Studies have found that NDLS can be more comfortable for patients than traditional forms of docetaxel, like Taxotere®. NDLS does not include certain ingredients, such as polysorbate 80 and ethanol, which can cause unwanted side effects.
In past cases, patients using NDLS experienced fewer side effects while achieving similar or better results compared to those using regular docetaxel. This suggests that NDLS might be a safer choice for treating advanced breast cancer, with fewer negative effects reported.
Overall, evidence supports that NDLS is well-tolerated by patients and has a promising safety profile.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Nanosomal Docetaxel Lipid Suspension (NDLS) because it offers a potentially safer and more effective approach for treating triple negative breast cancer. Unlike the standard treatment, Taxotere®, which can come with significant side effects, NDLS employs a lipid-based delivery system that may enhance the drug's ability to target cancer cells while reducing toxicity. This innovative delivery method could lead to fewer side effects and improved patient outcomes. The trial is examining two doses of NDLS (75 mg/m² and 100 mg/m²) to determine the optimal balance between efficacy and safety.
What evidence suggests that this trial's treatments could be effective for triple-negative breast cancer?
Research has shown that Nanosomal Docetaxel Lipid Suspension (NDLS) yields positive results in treating breast cancer. In this trial, participants will receive either NDLS at 75 mg/m² or 100 mg/m², or the active comparator, Taxotere® (Docetaxel Injection Concentrate) at 100 mg/m². Studies have found NDLS to be effective and easier for patients to tolerate, with better response rates than traditional docetaxel. This suggests it might work better and be easier for patients to handle. Additionally, NDLS has demonstrated similar results in controlling the disease and improving survival rates compared to standard treatments. These promising findings suggest that NDLS could be a strong option for treating triple-negative breast cancer.13456
Who Is on the Research Team?
Dr. Ravi Alamchandani
Principal Investigator
Lambda Therapeutic Research Ltd.
Are You a Good Fit for This Trial?
This trial is for patients with triple-negative breast cancer who have had one prior chemotherapy regimen and are not currently pregnant or breastfeeding. They must have a measurable lesion, an ECOG status of 0-2, normal heart function, and adequate organ function. Exclusions include hypersensitivity to Docetaxel, HER2 positive or hormone receptor-positive cancers, uncontrolled diabetes/infection, recent participation in another drug study, known brain metastases (unless asymptomatic), significant neuropathy or cardiac issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Nanosomal Docetaxel Lipid Suspension or Taxotere® every 3 weeks until disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nanosomal Docetaxel Lipid Suspension
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jina Pharmaceuticals Inc.
Lead Sponsor
Intas Pharmaceuticals, Ltd.
Industry Sponsor
Lambda Therapeutic Research Ltd.
Industry Sponsor