Chemotherapy for Advanced Breast Cancer

Not currently recruiting at 3 trial locations

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Must not be taking: Investigational agents, Corticosteroids

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days per cycle, up to 30 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of the chemotherapy drug nab-paclitaxel in treating breast cancer that has spread to nearby tissues or other parts of the body. Researchers aim to understand the side effects of this drug in older patients with advanced cancer. This study suits individuals with locally advanced or metastatic breast cancer considering nab-paclitaxel as a first or second treatment option. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot be on any other investigational drugs or have received a taxane in the last 12 months.

Is there any evidence suggesting that nab-paclitaxel is likely to be safe for humans?

Research shows that nab-paclitaxel is generally safe for treating advanced breast cancer. Studies have found it effective and manageable, even for patients who have undergone previous treatments. Another review confirmed nab-paclitaxel's safety at different stages of breast cancer. However, like many chemotherapy drugs, it can cause side effects. Some patients might experience low blood cell counts or fatigue. Discuss any concerns with a doctor to understand how this might affect treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Nab-paclitaxel is unique because it uses a special delivery system to enhance the effectiveness of chemotherapy for advanced breast cancer. Unlike traditional paclitaxel, which is often combined with solvents that can cause side effects, nab-paclitaxel is bound to albumin, a protein that helps it dissolve without solvents. This means it can potentially reduce side effects and improve drug delivery to the tumor. Researchers are excited because this approach could lead to better outcomes with fewer complications for patients.

What evidence suggests that nab-paclitaxel might be an effective treatment for advanced breast cancer?

Research has shown that nab-paclitaxel, the treatment under study in this trial, effectively treats advanced breast cancer that has spread to other parts of the body. In previous studies, patients receiving nab-paclitaxel achieved better results compared to those on other treatments. For instance, one study found that 42% of patients responded well to nab-paclitaxel, while only 29% responded well to another treatment. Another study highlighted that nab-paclitaxel generally has manageable side effects, making it a suitable option for many patients. Overall, nab-paclitaxel is considered a strong choice for those with advanced breast cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Mina Sedrak

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for older adults with breast cancer that has spread locally or to other body parts. Participants need a certain level of kidney function, blood cell counts, and liver health; they must understand the study and agree to participate. They should be relatively fit (KPS >= 70%) and not have had taxane drugs recently or severe nerve damage from past treatments.

Inclusion Criteria

I am receiving my first or second round of chemotherapy for cancer that has spread.

Your platelet count is at least 100,000 cells per cubic millimeter.

My alkaline phosphatase levels are normal or slightly elevated, and I don't have liver metastases.

Exclusion Criteria

I am allergic to paclitaxel.

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

Patients may not be receiving any other investigational agents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nab-paclitaxel intravenously over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

28 days per cycle, up to 30 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2.5 years

What Are the Treatments Tested in This Trial?

Interventions

• Nab-paclitaxel

Trial Overview The trial is testing nab-paclitaxel's effectiveness in managing advanced breast cancer in older patients. It looks at how well this chemotherapy drug works alone without combining it with other treatments, focusing on its safety profile and impact on tumor growth.

How Is the Trial Designed?

Group I: Treatment (nab-paclitaxel) Experimental Treatment 3 Interventions

Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Nab-paclitaxel is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Abraxane for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Adenocarcinoma of the pancreas

Approved in European Union as Abraxane for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Adenocarcinoma of the pancreas

Approved in Canada as Abraxane for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Adenocarcinoma of the pancreas

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

ABI-007, a solvent-free albumin-bound paclitaxel, showed significantly higher response rates (33% vs. 19%) and longer time to tumor progression (23.0 weeks vs. 16.9 weeks) compared to standard paclitaxel in a phase III study with 454 patients.

ABI-007 had a lower incidence of severe neutropenia (9% vs. 22%) and did not require premedication, indicating a better safety profile, although it was associated with a higher rate of manageable sensory neuropathy (10% vs. 2%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. Gradishar, WJ., Tjulandin, S., Davidson, N., et al.[2023]

In a phase II study involving 43 patients with non-small-cell lung cancer, Abraxane (260 mg/m2) demonstrated a 16% overall response rate and a 49% disease control rate, indicating its efficacy as a first-line therapy.

Abraxane was well tolerated, with no severe hypersensitivity reactions reported and only 5% of patients discontinuing treatment due to mild toxicities, suggesting a favorable safety profile for this novel formulation of paclitaxel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abraxane, a novel Cremophor-free, albumin-bound particle form of paclitaxel for the treatment of advanced non-small-cell lung cancer. Green, MR., Manikhas, GM., Orlov, S., et al.[2022]

Nab-paclitaxel (Abraxane) is an effective treatment for metastatic breast cancer, showing a superior therapeutic index compared to conventional paclitaxel in a Phase III study with a standard dose of 260 mg/m² every three weeks.

In patients with poor prognostic factors, nab-paclitaxel demonstrated rapid and significant tumor responses, indicating it may be particularly beneficial for those with more severe disease, and lower doses (100 and 150 mg/m² weekly) also showed promising efficacy, suggesting potential for dose tailoring in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the role of nab-paclitaxel (Abraxane) in women with aggressive metastatic breast cancer. Ciruelos, E., Jackisch, C.[2015]

ABI-007, a novel nanoparticle formulation of paclitaxel, demonstrated a significant overall response rate of 48% in treating metastatic breast cancer, with even higher rates of 64% for first-line therapy, indicating its efficacy in this patient population.

The treatment was well-tolerated, with no severe hypersensitivity reactions reported despite the absence of premedication, and typical toxicities associated with paclitaxel, such as neutropenia and sensory neuropathy, were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter phase II trial of ABI-007, an albumin-bound paclitaxel, in women with metastatic breast cancer. Ibrahim, NK., Samuels, B., Page, R., et al.[2022]

In a study involving 17 patients with malignant solid tumors, nab-paclitaxel (Abraxane) showed a significantly higher exposure to unbound paclitaxel compared to solvent-based paclitaxel, which may enhance its effectiveness against tumors.

The pharmacokinetics of nab-paclitaxel remained consistent across treatment cycles, indicating stable drug behavior and suggesting improved tolerability and efficacy due to its unique formulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized crossover pharmacokinetic study of solvent-based paclitaxel and nab-paclitaxel. Gardner, ER., Dahut, WL., Scripture, CD., et al.[2022]

Nanoparticle albumin-bound paclitaxel (ABI-007, Abraxane) is a safer alternative to conventional paclitaxel for breast cancer treatment, as it eliminates the need for toxic solvents and premedication.

Recent trials indicate that ABI-007 is well tolerated and offers superior outcomes compared to standard paclitaxel, including higher response rates, longer time to tumor progression, and extended survival in patients with metastatic breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nanoparticle albumin-bound paclitaxel (ABI-007): a newer taxane alternative in breast cancer. Moreno-Aspitia, A., Perez, EA.[2023]

Nab-paclitaxel was well tolerated in pediatric solid tumor models, with a maximum weight loss of about 10% that returned to baseline after treatment, indicating a favorable safety profile.

The treatment showed significant efficacy, improving event-free survival in 19 out of 20 solid tumor xenograft models, particularly demonstrating high activity against Ewing sarcoma and rhabdomyosarcoma, making it a promising candidate for further pediatric evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial testing (stage 1) of the tubulin binding agent nanoparticle albumin-bound (nab) paclitaxel (Abraxane(®)) by the Pediatric Preclinical Testing Program (PPTP). Houghton, PJ., Kurmasheva, RT., Kolb, EA., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9016319/

A Real-World Efficacy of Nab-Paclitaxel Monotherapy in ... This real-world data shows that nab-paclitaxel is a reasonable treatment option in heavily pre-treated and/or taxane-exposed metastatic breast cancer patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4465168/

nab-Paclitaxel dose and schedule in breast cancer - PMC Weekly sb-paclitaxel resulted in superior efficacy compared with treatment q3w in patients with MBC (ORR: 42 % vs 29 %, P = 0.0004; time to progression: 9 vs 5 ...

3. ijmio.com ijmio.com/real-world-study-on-the-effect-of-nab-paclitaxel-treatment-on-clinical-outcomes-and-laboratory-parameters-in-patients-across-metastatic-tumor-sites/

Real-world study on the effect of nab-paclitaxel treatment ... Nab-paclitaxel showed manageable tolerability and favorable response rates in metastatic cancer patients. It is widely used beyond approved indications.

4. nature.com nature.com/articles/s41598-019-57380-0

Efficacy and safety of nanoparticle-albumin-bound ... The studies were comparing the efficacy and safety between nab-paclitaxel chemotherapy versus solvent-based (sb)-taxanes chemotherapy such as sb-paclitaxel and ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.19.00877

Nab-Paclitaxel: A New Standard of Care in Neoadjuvant ... Moreover, median overall survival was improved with weekly nab-paclitaxel 150 mg/m2 compared with 100 mg/m2 (33.8 v 22.2 months). ... As a result, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28366406/

Nab-Paclitaxel in Advanced HER2-negative Breast Cancer ... Our real-life data indicate that both schedules of nab-paclitaxel are manageable and safe in advanced breast cancer patients, even if previously treated ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8286600/

A systematic review and meta-analysis of nab-paclitaxel mono ... Nab-paclitaxel in advanced HER2-negative breast cancer patients: efficacy and safety beyond clinical trials. Clin Breast Cancer. 2017;17(6): ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02250326

NCT02250326 | Safety and Efficacy Study of Nab®- ... This is a Phase 2, open-label, multicenter study to assess the efficacy and safety of second/third-line treatment with nab-paclitaxel in combination with ...

9. ehoonline.biomedcentral.com ehoonline.biomedcentral.com/articles/10.1186/s40164-017-0066-5

nab-Paclitaxel for the treatment of breast cancer Recent clinical data indicate that nab-paclitaxel is effective and safe across all stages of breast cancer. The results from trials in the ...

10. abraxanepro.com abraxanepro.com/metastatic-breast-cancer

ABRAXANE® for Metastatic Breast Cancer | for HCPs Learn about ABRAXANE® for metastatic breast cancer after relapse on certain chemotherapies. See full prescribing info and BOXED WARNINGS on neutropenia.