Nanoparticle Chemotherapy for Breast Cancer

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Must be taking: Paclitaxel

Must not be taking: Corticosteroids, Taxanes

Disqualifiers: CNS metastases, Allergic to paclitaxel, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days per cycle

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on other anticancer therapies or investigational agents while participating.

What data supports the effectiveness of the drug Paclitaxel Albumin-Stabilized Nanoparticle Formulation for breast cancer?

Research shows that nanoparticle albumin-bound paclitaxel has demonstrated antitumor activity in patients with metastatic breast cancer, even in those whose disease progressed despite previous treatments with conventional taxanes. ^{1 2 3 4 5}

Is nanoparticle albumin-bound paclitaxel safe for humans?

Nanoparticle albumin-bound paclitaxel is generally considered safer than solvent-based paclitaxel because it avoids severe allergic reactions related to solvents. However, it can still cause side effects like myelosuppression (a decrease in bone marrow activity) and peripheral neuropathy (nerve damage), which are common with paclitaxel treatments. ^{6 7 8 9 10}

What makes nanoparticle chemotherapy with albumin-bound paclitaxel unique for breast cancer?

This treatment uses albumin-bound nanoparticles to deliver paclitaxel, a chemotherapy drug, without the need for toxic solvents, allowing for safer administration and better targeting of the drug to tumors. It can be given without premedication and in a shorter time, making it more convenient and potentially less harmful than traditional solvent-based paclitaxel. ^{1 11 12 13 14}

What is the purpose of this trial?

RATIONALE: Gathering information from patients of different ages receiving paclitaxel albumin-stabilized nanoparticle formulation for metastatic breast cancer may help doctors understand how the age of the patient changes the way the drug works. PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients of different ages with metastatic breast cancer.

Research Team

Mina Sedrak, MD

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for individuals with metastatic breast cancer, regardless of hormone receptor status, who are planning to receive their first or second round of chemotherapy. It's not suitable for those with untreated brain metastases or symptoms needing increasing steroid doses.

Inclusion Criteria

My breast cancer has spread to other parts of my body.

My breast cancer can be any type, but I will be treated with a specific chemotherapy drug.

I am planning to start my first or second chemotherapy for advanced cancer.

Exclusion Criteria

I have brain metastases that haven't been treated or need more steroids to manage symptoms.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

28 days per cycle

Pharmacokinetic Studies

Blood is drawn for pharmacokinetic studies periodically during course 1.

Cycle 1

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with assessments for dose omissions, toxicity, and response.

Up to 2.5 years

Treatment Details

Interventions

• Paclitaxel Albumin-Stabilized Nanoparticle Formulation

Trial Overview The study focuses on how well a drug called paclitaxel albumin-stabilized nanoparticle formulation works in treating different age groups with advanced breast cancer. It includes cognitive and psychosocial assessments, pharmacological studies, and questionnaires.

Participant Groups

Group I: nab-paclitaxel Experimental Treatment 7 Interventions

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study involving women with metastatic breast cancer (MBC) who had previously failed taxane therapy, albumin-bound paclitaxel showed response rates of 14% and 16% for doses of 100 mg/m2 and 125 mg/m2, respectively, indicating its potential effectiveness in this patient population.

The 100 mg/m2 dose of albumin-bound paclitaxel not only demonstrated similar antitumor activity to the higher dose but also had a more favorable safety profile, with low rates of severe side effects like hypersensitivity reactions and grade 4 neutropenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of weekly albumin-bound paclitaxel for patients with metastatic breast cancer heavily pretreated with taxanes. Blum, JL., Savin, MA., Edelman, G., et al.[2023]

Albumin-bound paclitaxel has demonstrated significant clinical efficacy in treating metastatic breast cancer, as shown in phase II and III trials, making it a promising alternative to standard formulations.

This formulation is associated with better tolerance and safety compared to traditional solvent-based paclitaxel, suggesting it may reduce adverse effects for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Albumin-bound paclitaxel: the benefit of this new formulation in the treatment of various cancers. Montana, M., Ducros, C., Verhaeghe, P., et al.[2018]

References

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

Phase II study of weekly albumin-bound paclitaxel for patients with metastatic breast cancer heavily pretreated with taxanes. [2023]

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

Nanoparticle albumin-bound paclitaxel as neoadjuvant chemotherapy of breast cancer: a systematic review and meta-analysis. [2022]

3. China pubmed.ncbi.nlm.nih.gov

Efficacy and safety of nanoparticle-albumin-bound paclitaxel compared with conventional taxanes in women with breast cancer: a systematic review and meta-analysis. [2022]

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

Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) as second-line chemotherapy in HER2-negative, taxane-pretreated metastatic breast cancer patients: prospective evaluation of activity, safety, and quality of life. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Comparison between nab-paclitaxel and solvent-based taxanes as neoadjuvant therapy in breast cancer: a systematic review and meta-analysis. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Is nab-paclitaxel better than conventional taxanes as neoadjuvant therapy for breast cancer? A meta-analysis. [2021]

7. Japan pubmed.ncbi.nlm.nih.gov

A phase II, multicenter, single-arm study of tri-weekly low-dose nanoparticle albumin-bound paclitaxel chemotherapy for patients with metastatic or recurrent breast cancer. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Adverse event profiles of solvent-based and nanoparticle albumin-bound paclitaxel formulations using the Food and Drug Administration Adverse Event Reporting System. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Nanoparticle albumin-bound paclitaxel in a patient with locally advanced breast cancer and taxane-induced skin toxicity: a case report. [2021]

10. Japan pubmed.ncbi.nlm.nih.gov

[Results of a drug use investigation of nanoparticle albumin-bound Paclitaxel for breast cancer]. [2015]

11. England pubmed.ncbi.nlm.nih.gov

Enhancing intracellular taxane delivery: current role and perspectives of nanoparticle albumin-bound paclitaxel in the treatment of advanced breast cancer. [2015]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Optimizing taxane use in MBC in the emerging era of targeted chemotherapy. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Albumin-bound paclitaxel: the benefit of this new formulation in the treatment of various cancers. [2018]

14. China pubmed.ncbi.nlm.nih.gov

[Efficacy of albumin-bound paclitaxel in advanced gastric cancer patients]. [2018]