Paclitaxel for Breast Cancer

Overseen By Cancer AnswerLine

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Michigan Rogel Cancer Center

Must not be taking: CYP2C8 inducers, inhibitors

Disqualifiers: Hypersensitivity to paclitaxel, pregnant, 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: Up to 12 weeks

22 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a breast cancer treatment called paclitaxel. Researchers aim to determine if adjusting the infusion time for patients with low or weak muscle mass (sarcopenia) helps their bodies process the drug similarly to those with normal muscle mass. The trial includes two groups: one receives the standard infusion, while the other receives an adjusted infusion time for one dose. Women scheduled to receive paclitaxel and who have undergone certain scans in the past year might be suitable candidates. As a Phase 4 trial, this research seeks to understand how an already FDA-approved and effective treatment can benefit more patients.

Do I have to stop taking my current medications?

You may need to stop taking certain medications. The trial excludes participants who are taking moderate or strong inducers or inhibitors of CYP2C8, like rifampin or clopidogrel.

Will I have to stop taking my current medications?

You may need to stop taking certain medications that affect the enzyme CYP2C8, like rifampin or clopidogrel, as they are not allowed during the trial.

What is the safety track record for paclitaxel?

Research has shown that paclitaxel is a well-known treatment for breast cancer, with a long history of use that helps clarify its safety profile. Paclitaxel may cause side effects, such as reduced white blood cell counts, which can increase infection risk, and numbness or tingling in the hands and feet.

One study found that patients using a specific form of paclitaxel had a disease-free survival rate of about 84.9% over five years. However, combining paclitaxel with certain other drugs for specific types of breast cancer might not be safe.

Since this treatment is widely used and approved for other conditions, its safety is well-documented. Nonetheless, discussing any concerns with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike standard chemotherapy options for breast cancer, which typically follow a uniform infusion schedule, this trial explores a personalized infusion approach with paclitaxel. The treatment is unique because it adjusts the infusion time based on patients' skeletal muscle area (SMA), potentially offering a tailored treatment that could improve effectiveness and reduce side effects. Researchers are excited about this because customizing the infusion time might enhance how the drug works in different body compositions, making the treatment more effective and tolerable for patients with varying muscle mass.

What is the effectiveness track record for paclitaxel in treating breast cancer?

Research has shown that paclitaxel effectively treats breast cancer. This well-known chemotherapy drug is used for various cancers, including breast cancer. Studies have demonstrated that paclitaxel can shrink tumors and slow disease progression. Notably, it has proven effective even for patients who have tried many other cancer treatments. In this trial, participants will receive paclitaxel with either a standard infusion time or an adjusted infusion time based on specific criteria. Doctors widely recognize this treatment as a reliable option for managing breast cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

Daniel L Hertz, PharmD, PhD

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with Stage 1-3 breast cancer who are planning or undergoing neoadjuvant, adjuvant, or curative intent chemotherapy with paclitaxel. Participants must have adequate organ function and an evaluable CT scan from the past year. Pregnant or nursing individuals, those with hypersensitivity to paclitaxel components, or those on certain CYP2C8 inhibitors/inducers cannot join.

Inclusion Criteria

Evaluable computed tomography (CT) scan within 1 year

My breast cancer is at stage 1, 2, or 3.

My organs are working well enough for chemotherapy.

Exclusion Criteria

I am not taking medications like rifampin or clopidogrel that strongly affect liver enzymes.

History of hypersensitivity reaction to paclitaxel or any components of paclitaxel that precludes continued treatment with standard dose and infusion length

Pregnant or nursing

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive paclitaxel infusion with adjusted duration based on skeletal muscle area

Up to 12 weeks

Infusion visits as per treatment schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Paclitaxel

Trial Overview The study tests if extending the infusion time of paclitaxel in patients with low skeletal muscle area can normalize drug concentration levels compared to those with normal muscle area receiving a standard infusion duration.

How Is the Trial Designed?

Group I: Low SMA (5120 - 7310 mm^2) and Sarcopenic SMA (<5120 mm^2) Experimental Treatment 1 Intervention

Adjusted paclitaxel infusion time during only one dose; standard paclitaxel infusion time for all other doses.

Group II: Normal SMA (>7310 mm^2) Active Control 1 Intervention

Standard paclitaxel infusion time.

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

Published Research Related to This Trial

Nab-paclitaxel, a novel formulation of paclitaxel, has shown higher response rates and a better safety profile compared to conventional paclitaxel in a phase III clinical trial, making it a promising option for breast cancer treatment.

This formulation allows for higher doses to be administered over shorter infusion times without the need for special equipment or pre-medications, and it is now approved for use in patients with metastatic breast cancer after prior chemotherapy failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of nab-Paclitaxel in the Treatment of Patients with Breast Cancer. Vishnu, P., Roy, V.[2021]

A 55-year-old woman developed corneal disorders, including blurred vision and epithelial defects, after treatment with nab-paclitaxel, indicating that this microtubule inhibitor can cause significant ocular side effects.

After discontinuing nab-paclitaxel, her corneal condition improved dramatically, suggesting that the drug was the likely cause of her symptoms, although the potential contribution of other medications like trastuzumab and pertuzumab should also be considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A Case of a Corneal Disorder after Breast Cancer Treatment with Nab-paclitaxel]. Hosotani, Y., Morimatsu, T., Takata, M., et al.[2016]

Paclitaxel (Taxol) is a highly effective drug for treating breast cancer, particularly in patients with HER2-positive tumors, suggesting that HER2 status could guide treatment decisions.

Future research aims to refine treatment strategies by identifying specific criteria for paclitaxel use, potentially improving outcomes by avoiding unnecessary treatment in patients with lower likelihoods of benefit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Future directions of paclitaxel-based therapy of breast cancer. Gianni, L.[2015]

In a study of 30 women with advanced breast cancer, the combination of doxorubicin and paclitaxel resulted in a high overall response rate of 83%, with 24% achieving complete remission, indicating strong efficacy for this treatment regimen.

However, the treatment was associated with significant toxicities, including neutropenia and cardiotoxicity, with 50% of patients experiencing reduced heart function and 20% developing congestive heart failure, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined doxorubicin and paclitaxel in advanced breast cancer: effective and cardiotoxic. Gehl, J., Boesgaard, M., Paaske, T., et al.[2020]

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]

In a phase II study involving 25 patients with metastatic breast cancer, paclitaxel demonstrated significant efficacy, with 14 patients achieving a major response and a median survival time of 20 months.

Paclitaxel remains effective even in patients who have undergone multiple prior chemotherapy regimens, including those resistant to anthracyclines, although combination therapies can lead to serious side effects like neutropenic fever and neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The University of Texas M.D. Anderson Cancer Center experience with paclitaxel in breast cancer. Hortobagyi, GN., Holmes, FA., Ibrahim, N., et al.[2015]

Nab-paclitaxel (Abraxane(®)) has been approved by the FDA for treating breast cancer after chemotherapy failure, showing superior efficacy compared to traditional paclitaxel (Taxol(®)).

This new formulation not only demonstrates better effectiveness but also has less toxicity, which enhances its safety profile and therapeutic index, making it a promising option for combination therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nab-paclitaxel in the treatment of metastatic breast cancer: a comprehensive review. Montero, AJ., Adams, B., Diaz-Montero, CM., et al.[2021]

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]

Paclitaxel (Taxol) is a significant new chemotherapy drug for breast cancer, showing promise in both single-agent and combination treatments.

Ongoing research at Memorial Sloan-Kettering Cancer Center aims to optimize the use of paclitaxel in various treatment settings, including metastatic and adjuvant therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memorial Sloan-Kettering Cancer Center experience with paclitaxel in the treatment of breast cancer. Seidman, AD., Hudis, CA., Fennelly, D., et al.[2015]

Abraxane® demonstrated a significantly shorter drug delivery time (84 minutes) and lower overall costs (US$59 per dose) compared to Taxol® (282 minutes and US$254 per dose), making it a more efficient treatment option for advanced breast cancer.

Patients receiving Abraxane® experienced fewer acute adverse drug reactions (8.3%) compared to those treated with Taxol® (33.3%), indicating a potentially safer profile for Abraxane® in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abraxane® versus Taxol® for patients with advanced breast cancer: A prospective time and motion analysis from a Chinese health care perspective. Dranitsaris, G., Yu, B., Wang, L., et al.[2016]

Paclitaxel has shown promising efficacy in treating stage IV breast cancer, with overall response rates ranging from 44% to 62% in phase II trials, indicating it can be an effective option for patients with limited prior therapy.

The treatment is generally well tolerated, with febrile neutropenia being the most common side effect, and it has demonstrated safety and efficacy even in patients with extensive prior therapy, achieving response rates of 36% in those with two prior treatments and 21% in those with three or more.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-agent use of Taxol (paclitaxel) in breast cancer. Seidman, AD.[2016]

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. 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 ...

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

Nab-Paclitaxel: A New Standard of Care in Neoadjuvant ... Outcome Data for Trials of Nab-Paclitaxel in Metastatic Breast Cancer. A subsequent phase II trial in 302 patients with metastatic disease ...

4. clinical-breast-cancer.com clinical-breast-cancer.com/article/S1526-8209(18)30064-8/fulltext

Final Effectiveness and Safety Results of NABUCCO A total of 697 patients had evaluable data with a median follow-up of 17.7 months. Median time to progression was 5.9 months (95% confidence ...

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-021-08441-z

A systematic review and meta-analysis of nab-paclitaxel ... Patients who received first-line nab-paclitaxel monotherapy showed a higher ORR (P = 0.006) and longer PFS (P = 0.045). Efficacy outcomes were ...

6. 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 ...

7. oncologynewscentral.com oncologynewscentral.com/breast-cancer/comparison-of-paclitaxel-regimens-in-early-breast-cancer-raises-questions

Comparison of Paclitaxel Regimens in Early Breast Cancer ... Primary endpoints were five-year disease-free survival (DFS) and invasive disease-free survival (iDFS) rates. With nab-PAC, the DFS was 84.9% ...

8. 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.

9. facingourrisk.org facingourrisk.org/XRAY/FDA-warns-against-tecentriq-and-paclitaxel-combo-therapy

FDA issues alert on a drug combination to treat triple ... Patients with advanced triple-negative breast cancer (TNBC) should avoid taking the therapy drug Tecentriq with paclitaxel.