What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as docetaxel and its lipid-based formulations, are associated with side effects including neutropenia, febrile neutropenia, anemia, thrombocytopenia, fatigue, nausea, vomiting, diarrhea, and peripheral neuropathy. The lipid-based formulation of docetaxel (Nanosomal Docetaxel Lipid Suspension) aims to improve safety by reducing hypersensitivity reactions linked to excipients like polysorbate 80 and ethanol. Other treatments like paclitaxel also exhibit similar side effects, particularly hematologic toxicities and neuropathy.

What prior FDA approvals exist?

Docetaxel, marketed as Taxotere®, is a widely used chemotherapy agent for breast cancer, approved by the FDA for its efficacy in treating various stages of the disease. The Nanosomal Docetaxel Lipid Suspension (NDLS) is a novel formulation designed to improve the safety profile of docetaxel by eliminating harmful excipients like polysorbate 80 and ethanol. This lipid-based delivery system aims to reduce toxicity while maintaining the drug's efficacy. Similar approaches in cancer treatment have focused on enhancing drug delivery and minimizing side effects through innovative formulations.

What other types of research exist?

Promising novel alternatives to NDLS for breast cancer treatment include: 1) Lipid-conjugated estrogenic derivatives (e.g., ESC8) formulated as liposomes, solid lipid nanoparticles (SLNs), and nanostructured lipid carriers (NLCs), which have shown anticancer activity and enhanced drug delivery. 2) Nanoparticle albumin-bound paclitaxel (nab-paclitaxel), which has demonstrated improved efficacy and safety in various cancer types, including breast cancer. 3) Novel therapeutic nanoparticles (lipocores) designed to deliver poorly water-soluble compounds, which have shown reduced toxicity and enhanced therapeutic efficacy in preclinical models.

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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.

Must not have

Patients who are unwilling or unable to follow protocol requirements.

Uncontrolled diabetes or infection.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 years after study initiation

Awards & highlights

Pivotal Trial

Approved for 10 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial tests a new, safer form of the cancer drug docetaxel, called Nanosomal Docetaxel Lipid Suspension (NDLS), in patients with advanced or spreading triple-negative breast cancer. NDLS aims to reduce side effects by using tiny fat particles. The drug works by stopping cancer cells from dividing and growing. Docetaxel is a widely used chemotherapy drug, and newer formulations like Nanosomal Docetaxel Lipid Suspension (NDLS) aim to improve its efficacy and reduce 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.

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.

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 below

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My breast cancer is advanced and previous chemotherapy didn't work.

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I can take care of myself and am up and about more than half of my waking hours.

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My breast cancer is confirmed to be triple negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am willing and able to follow the study's requirements.

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I do not have uncontrolled diabetes or infections.

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I do not have recent or severe heart problems.

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I do not have severe nerve damage from previous treatments.

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My cancer is positive for HER2 and either estrogen or progesterone receptors.

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I have received Docetaxel for my cancer after it spread.

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I am diagnosed with HIV.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 years after study initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 • NCT01301729

59%

Leukopenia

56%

Neutropenia

34%

Hypoaesthesia

31%

Agranulocytosis

22%

Alopecia

22%

Asthenia

19%

Pyrexia

16%

Nail disorder

16%

Oedema peripheral

16%

Diarrhoea

16%

Hypophagia

13%

Alanine aminotransferase increased

13%

Neurotoxicity

13%

Cough

13%

Vomting

Musculoskeletal pain

Aspartate aminotransferase increased

Headache

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer, such as docetaxel, work by inhibiting cell division, which is essential for cancer cell growth. Docetaxel stabilizes microtubules, preventing their disassembly and leading to cell death. The Nanosomal Docetaxel Lipid Suspension (NDLS) improves upon this by using a lipid-based delivery system to eliminate harmful excipients, reduce side effects, and potentially enhance drug delivery to the tumor. This approach aims to provide more effective treatment with fewer adverse effects, improving outcomes and quality of life for breast cancer patients.

Extracellular vesicles from triple-negative breast cancer cells promote proliferation and drug resistance in non-tumorigenic breast cells.Biodistribution and Efficacy of Low Temperature-Sensitive Liposome Encapsulated Docetaxel Combined with Mild Hyperthermia in a Mouse Model of Prostate Cancer.Rapid decrease in delivery of chemotherapy to tumors after anti-VEGF therapy: implications for scheduling of anti-angiogenic drugs.