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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new formulation of a chemotherapy drug, Nanosomal Docetaxel Lipid Suspension (NDLS), to determine its effectiveness and safety for people with triple-negative breast cancer that has spread or is locally advanced. The study compares NDLS at two different doses with a standard treatment, Taxotere®, to identify which better controls the cancer. Individuals diagnosed with triple-negative breast cancer who have already tried ineffective chemotherapy might be suitable for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Nanosomal Docetaxel Lipid Suspension (NDLS) is generally easy for patients to handle in breast cancer treatments. Studies have found that NDLS can be more comfortable for patients than traditional forms of docetaxel, like Taxotere®. NDLS does not include certain ingredients, such as polysorbate 80 and ethanol, which can cause unwanted side effects.

In past cases, patients using NDLS experienced fewer side effects while achieving similar or better results compared to those using regular docetaxel. This suggests that NDLS might be a safer choice for treating advanced breast cancer, with fewer negative effects reported.

Overall, evidence supports that NDLS is well-tolerated by patients and has a promising safety profile. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Nanosomal Docetaxel Lipid Suspension (NDLS) because it offers a potentially safer and more effective approach for treating triple negative breast cancer. Unlike the standard treatment, Taxotere®, which can come with significant side effects, NDLS employs a lipid-based delivery system that may enhance the drug's ability to target cancer cells while reducing toxicity. This innovative delivery method could lead to fewer side effects and improved patient outcomes. The trial is examining two doses of NDLS (75 mg/m² and 100 mg/m²) to determine the optimal balance between efficacy and safety.

What evidence suggests that this trial's treatments could be effective for triple-negative breast cancer?

Research has shown that Nanosomal Docetaxel Lipid Suspension (NDLS) yields positive results in treating breast cancer. In this trial, participants will receive either NDLS at 75 mg/m² or 100 mg/m², or the active comparator, Taxotere® (Docetaxel Injection Concentrate) at 100 mg/m². Studies have found NDLS to be effective and easier for patients to tolerate, with better response rates than traditional docetaxel. This suggests it might work better and be easier for patients to handle. Additionally, NDLS has demonstrated similar results in controlling the disease and improving survival rates compared to standard treatments. These promising findings suggest that NDLS could be a strong option for treating triple-negative breast cancer. ^{1 3 4 5 6}

Who Is on the Research Team?

Dr. Ravi Alamchandani

Principal Investigator

Lambda Therapeutic Research Ltd.

Are You a Good Fit for This Trial?

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.

You have had a drug addiction in the past year.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32547188/

Nanosomal Docetaxel Lipid Suspension-Based ...

Conclusion: Nanosomal docetaxel lipid suspension-based chemotherapy was efficacious and well tolerated in the treatment of breast cancer.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT03671044?term=Docetaxel%20Anhydrous&viewType=Table&rank=5

A Study to Evaluate the Efficacy and Safety of Nanosomal ...

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 ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10075221/

Efficacy and Safety of Nanosomal Docetaxel Lipid ...

NDLS has demonstrated better response rates and tolerability in locally advanced or metastatic breast cancer (MBC) versus conventional docetaxel ...

4.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.e12591

Nanosomal docetaxel lipid suspension (NDLS) based (neo ...

NDLS based neo/adjuvant chemotherapy was efficacious in the treatment of breast cancer and showed comparable pCR, CR and OS rates versus conventional docetaxel.

5.

trialx.com

trialx.com/clinical-trials/listings/262279/a-study-to-evaluate-the-efficacy-and-safety-of-nanosomal-docetaxel-lipid-suspension-in-triple-negative-breast-cancer-patients/

A Study to Evaluate the Efficacy and Safety of Nanosomal ...

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 ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03671044?term=NCT03671044%26rank=1

A Study to Evaluate the Efficacy and Safety of Nanosomal ...

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 ...