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Anti-mitotic Agent
Nanosomal Docetaxel for Triple Negative Breast Cancer
Phase 3
Recruiting
Research Sponsored by Jina Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to two.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years after study initiation
Awards & highlights
Study Summary
This trial is testing a new docetaxel-lipid formulation, with the aim of improving safety, in patients with advanced or metastatic triple-negative breast cancer. 657 patients will be randomized to receive either the new formulation or Taxotere®. Patients will be monitored for disease progression and toxicity.
Who is the study for?
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.Check my eligibility
What is being tested?
The trial tests Nanosomal Docetaxel Lipid Suspension at two doses (75 mg/m2 and 100 mg/m2) against the standard Taxotere® at 100 mg/m2 in patients with advanced breast cancer. It aims to improve safety by eliminating certain excipients found in conventional formulations. The efficacy will be measured using RECIST guidelines across three groups of participants.See study design
What are the potential side effects?
Potential side effects may include those commonly associated with chemotherapy such as fatigue, nausea, hair loss, low blood cell counts leading to increased infection risk and bleeding problems; nerve damage causing pain or numbness; allergic reactions; and potential heart complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is advanced and previous chemotherapy didn't work.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My breast cancer is confirmed to be triple negative.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 2 years after study initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years after study initiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of the patients with Objective Response Rate (i.e., CR + PR) as the Best Overall Response Rate (i.e., CR + PR) in the test arm (NDLS) compared to reference arm (Taxotere)
Secondary outcome measures
Incidence of adverse events as assessed by clinical examination, and/or laboratory parameters
Progression free survival (PFS)
To evaluate the overall survival (OS) of the patients
Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: T2, Nanosomal Docetaxel Lipid Suspension (100 mg/m2)Experimental Treatment1 Intervention
Experimental: NDLS for Injection, 100 mg/ m2 Nanosomal Docetaxel Lipid Suspension for Injection; Dose: 100 mg/m2; Frequency: Every 3-weeks; Duration of treatment: Patient will be dosed with drug until disease progression and/or unacceptable toxicity
Group II: Nanosomal Docetaxel Lipid Suspension - 75 mg/m2Experimental Treatment1 Intervention
Experimental: NDLS for Injection, 75 mg/ m2 Nanosomal Docetaxel Lipid Suspension for Injection; Dose: 75 mg/m2; Frequency: Every 3-weeks; Duration of treatment: Patient will be dosed with drug until disease progression and/or unacceptable toxicity
Group III: R, Taxotere® (100 mg/m2)Active Control1 Intervention
Active Comparator: Taxotere® Injection Concentrate Docetaxel Injection Concentrate; Dose: 100 mg/m2; Frequency: Every 3-weeks; Duration of treatment: Patient will be dosed with drug until disease progression and/or unacceptable toxicity
Find a Location
Who is running the clinical trial?
Jina Pharmaceuticals Inc.Lead Sponsor
2 Previous Clinical Trials
137 Total Patients Enrolled
Intas Pharmaceuticals, Ltd.Industry Sponsor
3 Previous Clinical Trials
468 Total Patients Enrolled
Lambda Therapeutic Research Ltd.Industry Sponsor
7 Previous Clinical Trials
1,228 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow the study's requirements.I do not have uncontrolled diabetes or infections.You have had a drug addiction in the past year.My breast cancer is advanced and previous chemotherapy didn't work.You have had allergic reactions to Docetaxel or any of its ingredients, or to any drugs containing polysorbate 80.I have recovered from side effects of my previous cancer treatments.Before starting the study, a test needs to show that you are not pregnant.My kidney, liver, and bone marrow are functioning well.I have brain metastases but no symptoms.I am using effective birth control or am not of childbearing potential.I finished my last chemotherapy or radiotherapy at least 4 weeks ago.I do not have recent or severe heart problems.I do not have severe nerve damage from previous treatments.You have a visible and measurable tumor according to specific guidelines.I can take care of myself and am up and about more than half of my waking hours.My cancer is positive for HER2 and either estrogen or progesterone receptors.Your heart pumps out at least 50% of the blood when it contracts, as measured by an echocardiogram.I have received Docetaxel for my cancer after it spread.I have had only one chemotherapy treatment for early-stage cancer and/or one for advanced cancer.My breast cancer is confirmed to be triple negative.I am diagnosed with HIV.
Research Study Groups:
This trial has the following groups:- Group 1: R, Taxotere® (100 mg/m2)
- Group 2: Nanosomal Docetaxel Lipid Suspension - 75 mg/m2
- Group 3: T2, Nanosomal Docetaxel Lipid Suspension (100 mg/m2)
Awards:
This trial has 4 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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