Nanosomal Docetaxel for Triple Negative Breast Cancer

Recruiting at 3 trial locations

Overseen By Mr. Prashant Modi

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Jina Pharmaceuticals Inc.

Must not be taking: Docetaxel

Disqualifiers: Cardiac conditions, Uncontrolled diabetes, CNS lesions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: Variable (until disease progression or unacceptable toxicity)

657 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you must have recovered from any toxic effects of previous chemotherapy or radiotherapy, and these treatments should be completed 4 weeks before starting the trial medication.

What data supports the effectiveness of the drug Nanosomal Docetaxel Lipid Suspension for treating triple negative breast cancer?

Research shows that Nanosomal Docetaxel Lipid Suspension (NDLS) has been effective in treating various types of breast cancer, including metastatic and primary operable breast cancer, by reducing toxicity compared to conventional docetaxel. This suggests it may also be effective for triple negative breast cancer. ^{1 2 3 4 5}

Is Nanosomal Docetaxel Lipid Suspension safe for humans?

Nanosomal Docetaxel Lipid Suspension (NDLS) has been studied for safety in breast cancer and sarcoma patients, showing a favorable safety profile compared to conventional docetaxel. It was developed to reduce side effects by removing certain additives, and has been used safely in a pregnant woman with breast cancer, resulting in the birth of a healthy child. ^{1 2 4 5 6}

How is the drug Nanosomal Docetaxel Lipid Suspension different from other treatments for triple negative breast cancer?

Nanosomal Docetaxel Lipid Suspension (NDLS) is unique because it uses a lipid-based delivery system that eliminates the need for polysorbate 80 and ethanol, which are present in conventional docetaxel and can cause allergic reactions and other side effects. This means NDLS can be administered without the need for premedication with corticosteroids, making it potentially safer and more convenient for patients. ^{1 2 4 5 7}

What is the purpose of this trial?

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.

Research Team

Dr. Ravi Alamchandani

Principal Investigator

Lambda Therapeutic Research Ltd.

Eligibility Criteria

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.

Inclusion Criteria

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

I have recovered from side effects of my previous cancer treatments.

Patients with life expectancy of at least 6 months.

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive Nanosomal Docetaxel Lipid Suspension or Taxotere® every 3 weeks until disease progression or unacceptable toxicity

Variable (until disease progression or unacceptable toxicity)

Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 2 years

Treatment Details

Interventions

• Nanosomal Docetaxel Lipid Suspension

Trial Overview 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.

Participant Groups

Group I: T2, Nanosomal Docetaxel Lipid Suspension (100 mg/m2) Experimental Treatment 1 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/m2 Experimental Treatment 1 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 Control 1 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

Who Is Running the Clinical Trial?

Jina Pharmaceuticals Inc.

Lead Sponsor

Trials

7

Recruited

1,700+

Intas Pharmaceuticals, Ltd.

Industry Sponsor

Trials

4

Recruited

1,100+

Lambda Therapeutic Research Ltd.

Industry Sponsor

Trials

8

Recruited

1,900+

Findings from Research

In a study of 11 patients with sarcoma, nanosomal docetaxel lipid suspension (NDLS) chemotherapy showed promising efficacy, with a 50% overall response rate and a 66.7% disease control rate in metastatic cases, indicating its potential effectiveness in treating this type of cancer.

NDLS-based chemotherapy was well tolerated, with no new safety concerns identified, although 63.6% of patients experienced at least one adverse event, primarily hematological and gastrointestinal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Sarcoma: A Multicenter, Retrospective Study. Narayanan, P., Dattatreya, PS., Prasanna, R., et al.[2022]

The nanosomal docetaxel lipid suspension (NDLS) formulation showed a better overall therapeutic response rate of 35.5% compared to 26.3% for the traditional Taxotere in metastatic breast cancer patients, based on a study involving 72 patients.

NDLS can be administered without the need for premedication with corticosteroids, and its safety profile is comparable to that of Taxotere, making it a promising alternative treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic efficacy of a novel nanosomal docetaxel lipid suspension compared with taxotere in locally advanced or metastatic breast cancer patients. Ahmad, A., Sheikh, S., Taran, R., et al.[2018]

In a study of 91 breast cancer patients treated with nanosomal docetaxel lipid suspension (NDLS), the treatment showed a 100% overall response rate (ORR) in the neoadjuvant setting and a 64.7% ORR in the metastatic setting, indicating strong efficacy.

NDLS-based chemotherapy was well tolerated, with 59.3% of patients experiencing at least one adverse event, primarily hematological issues like anemia and neutropenia, but no new safety concerns were identified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Breast Cancer: Results from a Multicenter Retrospective Study. Subramanian, S., Prasanna, R., Biswas, G., et al.[2023]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension (NDLS) versus Conventional Docetaxel as Neoadjuvant and Adjuvant Therapy for Primary Operable Breast Cancer. [2023]

2. Egypt pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Sarcoma: A Multicenter, Retrospective Study. [2022]

3. Egypt pubmed.ncbi.nlm.nih.gov

A Multicentric, Retrospective Efficacy and Safety Study of Nanosomal Docetaxel Lipid Suspension in Metastatic Castration-Resistant Prostate Cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Therapeutic efficacy of a novel nanosomal docetaxel lipid suspension compared with taxotere in locally advanced or metastatic breast cancer patients. [2018]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Breast Cancer: Results from a Multicenter Retrospective Study. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Nanosomal docetaxel lipid suspension based chemotherapy in a pregnant MBC patient - a case report. [2020]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Nanosomal Docetaxel Lipid Suspension: A Guide to Its Use in Cancer. [2018]