RecruitingPhase 3

A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections, Heart tracing (ECG), Physical exams

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Docetaxel Lipid Suspension for Injection 20 mg/80 mg was approved for marketing in India."
  • "Intas Pharmaceuticals Ltd., is marketing this drug in India under the Brand name of DOCEAQUALIP 20/80 (Nanosomal Docetaxel Lipid Suspension for Injection 20/80 mg/vial) since 2013."
  • "Safety variables include AEs, clinical laboratory parameters, vital signs, physical examinations and electrocardiogram etc."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two doses of NDLS, a fat-based form of the cancer drug docetaxel, with standard docetaxel (Taxotere). It tests how well they work and how safe they are for people with triple-negative breast cancer that has spread nearby or to other parts of the body after earlier chemotherapy failed.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a consent form agreeing to join the study.
  • Have triple-negative breast cancer confirmed by tissue or cell testing. This cancer lacks three markers used to guide treatment.
  • Have cancer that has spread nearby or farther away after chemotherapy failed, with at least one tumor that can be measured. One earlier chemotherapy plan after surgery and/or one first chemotherapy plan for cancer that spread is allowed.
  • Be able to care for yourself and be out of bed or a chair for at least half of waking hours. Be expected to live at least 6 months.
  • Have a heart scan showing a pumping level of at least 50%, and have healthy enough bone marrow, kidneys, and liver.
  • Have finished chemotherapy or radiation at least 4 weeks before study treatment and recovered from its harmful effects, as judged by the study doctor.
  • Have negative blood and urine pregnancy tests at the required study visits.
  • If sexually active and able to become pregnant, use an allowed way to prevent pregnancy from at least 4 weeks before treatment until 30 days after the last dose. Hormonal birth control needs a second method.

Who can't join

  • Have had an allergic reaction to docetaxel, an ingredient in the study drug, or a drug containing polysorbate 80.
  • Have a history of breast cancer positive for HER2 and hormone receptors, or have already received docetaxel for cancer that spread to other parts of the body.
  • Have certain serious heart problems, including a heart attack in the past 6 months, unstable chest pain, or serious heartbeat or heart-pumping problems.
  • Have uncontrolled diabetes, an uncontrolled infection, HIV, or a history of drug addiction within the past year.
  • Have cancer in the brain or its lining, unless it is brain cancer spread that causes no symptoms.
  • Have moderate or worse nerve damage affecting movement or feeling.
  • Have taken an experimental drug or joined another drug study within 30 days before the first study dose.
  • Cannot or will not follow study rules, or have another condition the study doctor thinks could raise risks or affect the study results.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (3)

GA

  • Columbus Regional Research Institute, LLC · Columbus, GA 31904Heather Wicker · Study contact · 706-780-6201Andrew Pippas, MD · Principal investigatorMore trials in Columbus

MO

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