Evaluating a new formulation of Docetaxel for treating triple negative breast cancer

A Global, Multicenter, Three Arms, Open-label Randomized Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension Compared to Taxotere® (Docetaxel Injection Concentrate) in Triple-negative Breast Cancer Patients With Locally Advanced or Metastatic Breast Cancer After Failure to Prior Chemotherapy

This study is testing a new version of a breast cancer drug called Docetaxel to see if it works better and is safer for people with triple-negative breast cancer compared to the standard treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 657 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: Jina Pharmaceuticals Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 4 sites (Columbus, Georgia and 3 other locations)
• Trial ID: NCT03671044 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Nanosomal Docetaxel Lipid Suspension (NDLS) in patients with triple-negative breast cancer. The study compares two doses of NDLS (75 mg/m2 and 100 mg/m2) against the conventional Taxotere® (100 mg/m2). It is a randomized, open-label trial involving 657 patients, with tumor responses assessed using RECIST 1.1 guidelines. The aim is to improve the safety profile of docetaxel by eliminating harmful excipients found in traditional formulations.

Who should consider this trial

Good fit: Ideal candidates are patients with histologically confirmed triple-negative breast cancer who have locally advanced or metastatic disease after prior chemotherapy.

Not a fit: Patients with non-triple-negative breast cancer or those who have not recovered from previous chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a safer and more effective option for patients with triple-negative breast cancer.

How similar studies have performed: Other studies have shown promise with similar lipid-based formulations, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. The patient willing to give written signed and dated informed consent to participate in the study.
2. Patient must have histopathologically or cytologically confirmed triple negative breast cancer.
3. Patients may have received one prior chemotherapy regimen for adjuvant therapy and/or one chemotherapy treatment/regimen for firstline metastatic therapy
4. Patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.
5. Have at least one measurable lesion as per the RECIST criteria (version 1.1).
6. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to two
7. Left Ventricular Ejection fraction (LVEF) greater than or equal to 50 percentage as per Echocardiography (ECHO).
8. Patient must have recovered from any toxic effects of previous chemotherapy or radiotherapy as judged by the Investigator.
9. Previous chemotherapy or radiotherapy should be completed 4 weeks prior to start of IMP administration.
10. Patients with life expectancy of at least 6 months.
11. Serum pregnancy test at screening and urine pregnancy test on Day 1 (before randomization) must be negative.
12. Sexually active women, unless surgically sterile or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives \[any hormonal method in conjunction with a secondary method\], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile \[at least 6 months prior to Study drug administration\] sexual partner) for at least four weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.
13. Patient with adequate bone marrow, renal and hepatic function.

Exclusion Criteria:

1. Patient who has a history of hypersensitivity reactions to Docetaxel or any other component of formulation or to any drugs formulated with polysorbate 80.
2. Patients with a history of HER2 positive over expression and hormone receptor positive (ER or PR)
3. Patient who is already exposed to Docetaxel injection in metastatic setting.
4. Any of the cardiac conditions like Unstable angina, Myocardial infarction within the past six months, Severe uncontrolled ventricular arrhythmias, Clinically significant pericardial disease, Electrocardiographic evidence of acute ischemia, Patient with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) except in whom the disease has been stable for the past six months, History of cardiac disease that met the NYHA Classification class 2 or greater
5. Uncontrolled diabetes or infection.
6. Known history of drug addiction within last one year.
7. Patients with known CNS lesions (brain metastasis or carcinomatous meningitis) except for asymptomatic brain metastases.
8. The receipt of an investigational medicinal product or participation in other drug research study within a period of 30 days prior to the first dose of investigational medicinal Product for the current study.
9. Pre-existing motor or sensory neurotoxicity of a severity greater than or equal to grade two as defined by NCI CTCAE 4.03 criteria.
10. Known case of HIV infection.
11. Any other condition that, in the investigator's judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
12. Patients who are unwilling or unable to follow protocol requirements

Where this trial is running

Columbus, Georgia and 3 other locations

• Columbus Regional Research Institute, LLC — Columbus, Georgia, United States (Recruiting)
• Cox Medical Center — Springfield, Missouri, United States (Recruiting)
• Gabrail Cancer Center — Canton, Ohio, United States (Recruiting)
• Kailash Cancer Hospital & Research Centre — Vadodara, Gujarat, India (Recruiting)

Study contacts

• Study coordinator: Mr. Prashant Modi

Conditions Triple Negative Breast Cancer; Docetaxel