Paclitaxel for Breast Cancer

Overseen By Cancer Connect

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Wisconsin, Madison

Must be taking: Paclitaxel

Must not be taking: Non-aspirin anticoagulants

Disqualifiers: HIV, Severe infection, Heart failure, 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: 12

Duration: 12 weeks

50 Participants Needed

Trial Summary

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

The trial protocol does not specify if you need to stop taking your current medications, but you cannot take other investigational or commercial therapeutic agents at the same time as paclitaxel. If you are on non-aspirin blood thinners, you will be excluded from the trial.

What data supports the effectiveness of the drug Paclitaxel for breast cancer?

Research shows that Paclitaxel, including its formulation as Abraxane, is effective in treating metastatic breast cancer, even in cases resistant to other treatments. Studies have demonstrated its ability to achieve significant responses in patients, with Abraxane offering less toxicity and shorter infusion times compared to traditional formulations like Taxol. ^{1 2 3 4 5}

Is paclitaxel safe for humans?

Paclitaxel, including its formulation as nab-paclitaxel (Abraxane), is generally considered safe for humans, with studies showing it is well tolerated. It has fewer side effects compared to traditional formulations, though some side effects like febrile neutropenia (fever with low white blood cell count) and rare cases of corneal disorders have been reported. ^{3 6 7 8 9}

How is paclitaxel different from other breast cancer drugs?

Paclitaxel is unique because it can be formulated as nanoparticle albumin-bound paclitaxel (nab-paclitaxel), which does not require a toxic solvent, making it safer and potentially more effective with less toxicity compared to traditional paclitaxel. This formulation allows for higher concentrations in the tumor, leading to better outcomes in metastatic breast cancer. ^{1 3 4 10 11}

What is the purpose of this trial?

The hypothesis of this study is that paclitaxel levels increase chromosomal instability (CIN) in tumors and this is lethal to tumors that have pre-existing CIN. Treatment will be administered on an outpatient basis. Paclitaxel will be initiated as standard infusions on days 1, 8, and 15 of a 21-day cycle. Participants will continue with paclitaxel for cycles 2-4 prior to surgery.

Research Team

Mark E. Burkard, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for women with breast cancer who are eligible for neoadjuvant paclitaxel chemotherapy. They must not have metastatic disease, should not have received prior systemic chemotherapy for their current breast cancer, and must be able to undergo biopsies and imaging tests.

Inclusion Criteria

I have been diagnosed with breast cancer through a biopsy.

My doctor has approved me for a specific chemotherapy before surgery, without other experimental treatments.

My cancer has not spread to other parts of my body according to recent tests.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly paclitaxel infusions on days 1, 8, and 15 of a 21-day cycle for 4 cycles prior to surgery

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue to be monitored for long-term outcomes and additional data collection

Up to 3 months

Treatment Details

Interventions

• Paclitaxel

Trial Overview The study is testing if weekly treatments of Paclitaxel before surgery can help treat breast cancer by increasing chromosomal instability in tumors. The treatment spans over four cycles of three weeks each, with infusions on days 1, 8, and 15.

Participant Groups

Group I: Weekly Paclitaxel Experimental Treatment 1 Intervention

Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle. Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

The University of Texas M.D. Anderson Cancer Center experience with paclitaxel in breast cancer. [2015]

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

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

3. England pubmed.ncbi.nlm.nih.gov

Nab-paclitaxel in the treatment of metastatic breast cancer: a comprehensive review. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Combined doxorubicin and paclitaxel in advanced breast cancer: effective and cardiotoxic. [2020]

5. England 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. [2016]

6. Japan pubmed.ncbi.nlm.nih.gov

[A Case of a Corneal Disorder after Breast Cancer Treatment with Nab-paclitaxel]. [2016]

7. United States 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). [2022]

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

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

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

Safety and Efficacy of nab-Paclitaxel in the Treatment of Patients with Breast Cancer. [2021]

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

Memorial Sloan-Kettering Cancer Center experience with paclitaxel in the treatment of breast cancer. [2015]

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

Nanoparticle albumin-bound paclitaxel (ABI-007): a newer taxane alternative in breast cancer. [2023]