Nanoparticle Chemotherapy for Breast Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new chemotherapy treatment using paclitaxel formulated with nanoparticles to evaluate its effectiveness for people with metastatic breast cancer. Researchers aim to understand how patients of different ages respond to the treatment. It is suitable for those with metastatic breast cancer planning to start their first or second chemotherapy treatment. Participants should not have untreated or worsening brain metastases and should not be allergic to paclitaxel. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in cancer therapy.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that nab-paclitaxel effectively treats breast cancer. Studies suggest that nab-paclitaxel may be safer than the older version of the drug, which causes more side effects.

Nab-paclitaxel has its own side effects. Some patients experienced nerve damage, known as neuropathy, which can cause pain or numbness. In one study, eight patients had to lower their doses due to neuropathy, although most cases were not severe. This indicates that while nab-paclitaxel is generally well-tolerated, side effects can still occur, especially at higher doses.

Overall, nab-paclitaxel has demonstrated better safety compared to older versions of the drug. However, like all treatments, it may still cause some side effects. It's important to weigh both the potential benefits and risks when considering joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

Unlike the standard chemotherapy treatments for breast cancer, which often involve drugs like traditional paclitaxel, the nab-paclitaxel formulation uses albumin-stabilized nanoparticles to deliver the drug. This unique delivery method allows for better penetration of the tumor, potentially improving the drug's effectiveness while reducing some of the harsh side effects associated with standard chemotherapy. Researchers are excited because this approach not only targets the cancer cells more precisely but also enhances the drug's solubility, offering a promising improvement in treatment outcomes for patients with breast cancer.

What evidence suggests that this treatment might be an effective treatment for metastatic breast cancer?

Research has shown that nab-paclitaxel, a special form of chemotherapy, effectively treats advanced breast cancer. Studies have found that nab-paclitaxel outperforms traditional chemotherapy drugs. This form of the drug is designed to reach tumors more efficiently, enhancing its effectiveness. Clinical trials demonstrated improved outcomes for breast cancer patients. Additionally, it tends to cause fewer severe side effects, making it a promising treatment option. ^{1 2 6 7 8}

Who Is on the Research Team?

Mina Sedrak, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

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clinicaltrials.gov/study/NCT00609791

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8317518/

A Systemic Review and Meta-analysis - PMC

Background: Nanoparticle albumin-bound paclitaxel (nab-PTX) has exhibited clinical efficacy in breast cancer treatment, but toxicities can be yielded more ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5649768/

A Retrospective Study of Efficacy and Safety of Albumin ...

Nab-paclitaxel is widely approved for the treatment of metastatic breast cancer (MBC) on the basis of results from pivotal trials showing that it has superior ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT00609791?tab=history&a=35

Record History | ver. 35: 2024-02-14 | NCT00609791

PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients of different ages with ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1359634910700021

Nanoparticle albumin-bound (nab™)-paclitaxel: improving ...

Clinical trials in first- and second-line MBC show that nab-paclitaxel is both more effective than solvent-based taxanes and associated with less severe ...

6.

nature.com

nature.com/articles/s41598-025-16848-y

Distinct safety profiles of albumin-bound nab-paclitaxel and ...

These results emphasize the differential safety profiles of Nab-paclitaxel and paclitaxel, highlighting the unique safety considerations ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0960977611001305

Management of breast cancer with nanoparticle albumin- ...

Monotherapy with nanoparticle albumin-bound (nab)-paclitaxel has demonstrated improved efficacy and safety compared with solvent-based paclitaxel and ...

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ascopubs.org

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Dose-dense nab-paclitaxel (nanoparticle albumin-bound ...

In the full cohort, 8 patients had nab-paclitaxel dose reduction, 4 for neuropathy, while other neuropathy was moderate (grade 2, n = 6; grade 3 ...