Study on the Effectiveness and Safety of Nanosomal Docetaxel Lipid Suspension in Patients with Triple Negative Breast Cancer

Sponsor: Jina Pharmaceuticals Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03671044

Provider View

This clinical trial is testing a new form of the drug docetaxel, called Nanosomal Docetaxel Lipid Suspension (NDLS), to see if it is safe and effective for treating patients with advanced or spreading triple-negative breast cancer. The study compares NDLS to the standard treatment, Taxotere®, in terms of safety and effectiveness.

Patient Parameters

Program Overview

The study aims to evaluate a new formulation of the cancer drug docetaxel, known as Nanosomal Docetaxel Lipid Suspension (NDLS), which is designed to be safer by removing certain additives found in the traditional version. This trial will compare NDLS at two different doses to the standard treatment, Taxotere®, in patients with advanced or metastatic triple-negative breast cancer. A total of 657 patients will participate, and their cancer status will be monitored using specific guidelines to assess how well the treatment works.

Description

This study involves a new version of the cancer drug docetaxel, called Nanosomal Docetaxel Lipid Suspension (NDLS), which is designed to be safer by eliminating certain additives. The trial will compare NDLS at doses of 75 mg/m2 and 100 mg/m2 to the standard treatment, Taxotere®, at 100 mg/m2, in patients with advanced or metastatic triple-negative breast cancer.

Participants will be randomly assigned to one of the treatment groups and will continue treatment as long as it is effective and side effects are manageable. The effectiveness of the treatment will be evaluated using imaging tests like CT or MRI scans, and bone scans, every three treatment cycles. Patients will be monitored for side effects, and their health will be assessed through various tests, including blood tests and heart monitoring.

Patients will be screened up to 14 days before starting treatment and will receive their first dose on the first day of the study. They will need to arrive at the clinic two hours before dosing and stay until the treatment is completed. Hospitalization is optional, but medical supervision will be provided throughout the study to ensure patient safety. All safety data will be collected and analyzed to understand the treatment's impact on patients' health.

Eligibility Criteria

Inclusion Criteria

  • Willing to provide written consent to participate.
  • Diagnosed with triple-negative breast cancer confirmed by lab tests.
  • May have received one prior chemotherapy treatment for early-stage cancer or one for advanced cancer.
  • Have advanced or metastatic breast cancer that did not respond to previous chemotherapy.
  • Have at least one tumor that can be measured using standard criteria.
  • In good general health with a performance status score of 0 to 2.
  • Heart function must be at least 50% as measured by an echocardiogram.
  • Recovered from any side effects of previous cancer treatments.
  • Completed any previous chemotherapy or radiation at least four weeks before starting the study treatment.
  • Expected to live at least six more months.
  • Negative pregnancy test for women of childbearing potential.
  • Women must use effective birth control during the study and for 30 days after the last dose.
  • Have adequate bone marrow, kidney, and liver function.

Exclusion Criteria

  • History of allergic reactions to docetaxel or similar drugs.
  • History of HER2 positive or hormone receptor positive breast cancer.
  • Previously treated with docetaxel for metastatic cancer.
  • Serious heart conditions or recent heart attack.
  • Uncontrolled diabetes or infections.
  • History of drug addiction in the past year.
  • Known brain metastases or cancer spread to the brain, unless asymptomatic.
  • Participation in another drug study within 30 days before starting this study.
  • Severe nerve damage.
  • Known HIV infection.
  • Any condition that might increase risk or affect study results.
  • Unwilling or unable to follow study requirements.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.