Docetaxel vs Paclitaxel for Breast Cancer

Not currently recruiting at 502 trial locations

Overseen By Diana H. Griffiths

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: ECOG-ACRIN Cancer Research Group

Must not be taking: Taxanes, Platinums

Disqualifiers: Peripheral neuropathy, High bilirubin, 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: 6

Duration: 12-18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a genetic marker can identify African American women with stages I-III breast cancer who face a higher risk of nerve damage from chemotherapy. It also compares two chemotherapy drugs, docetaxel (known as Taxotere, Docefrez, Docivyx, DTX, or DXL) and paclitaxel (known as Taxol, Onxol, or Abraxane), to assess which causes less nerve damage. Women diagnosed with breast cancer within the last 84 days and planning to receive one of these treatments might be suitable candidates. Participants should self-identify as black, African American, or of African descent and must not have undergone certain prior cancer treatments. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that docetaxel-based chemotherapy is generally safe for patients with early breast cancer. Studies involving many women found no major safety issues. However, some patients might experience side effects, ranging from mild to severe.

For paclitaxel, research indicates it is well tolerated. The most common side effect is mild nerve damage, causing tingling or numbness. Although some people reported more severe nerve issues, these usually improved quickly.

Both treatments have demonstrated safety for many patients, but individual experiences may vary. Discussing possible side effects with a healthcare provider can help patients understand what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments, docetaxel and paclitaxel, for breast cancer because they offer different approaches to the standard chemotherapy options. Docetaxel is administered less frequently, once every three weeks, and can be combined with other potent drugs like cyclophosphamide and doxorubicin, potentially enhancing treatment effectiveness. Paclitaxel, on the other hand, is given weekly and may be paired with targeted therapies like trastuzumab and pertuzumab, which are tailored to attack specific cancer cells. These variations in administration and combination therapy options offer promise for improved patient outcomes and potentially lessened side effects compared to more traditional treatment plans.

What evidence suggests that this trial's treatments could be effective for breast cancer?

This trial will compare the effectiveness of docetaxel and paclitaxel for breast cancer treatment. Research has shown that docetaxel can effectively treat breast cancer. One study found that patients with advanced breast cancer lived longer when treated with docetaxel compared to paclitaxel. Another study demonstrated that using docetaxel alongside other treatments improved survival rates for breast cancer patients.

Paclitaxel, which participants in this trial may receive, has also shown promise in treating breast cancer. In one study, paclitaxel increased the rate of complete response when used with another drug. Both treatments have evidence supporting their effectiveness, but docetaxel may help some patients live longer. ^{6 7 8 9 10}

Who Is on the Research Team?

Bryan P Schneider

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

This trial is for African American women with stage I-III breast cancer who plan to receive specific chemotherapy treatments (docetaxel or paclitaxel) and have not had prior taxane, platinum, or vinca alkaloid therapy. They should not be pregnant, lactating, nor have pre-existing peripheral neuropathy. Participants must be in good health as indicated by blood tests and an ECOG performance status of 0-1.

Inclusion Criteria

I have not been treated with taxane or platinum-based drugs.

Patients must not be pregnant or lactating

Your liver enzymes (AST and ALT) and alkaline phosphatase levels must not be too high.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either paclitaxel or docetaxel intravenously, with treatment cycles repeating every 21 days for 4-6 cycles

12-18 weeks

Weekly visits for paclitaxel, every 3 weeks for docetaxel

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Every 3 months for 2 years, then every 6 months for 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Docetaxel
• Paclitaxel

Trial Overview The study is testing whether docetaxel or paclitaxel can reduce chemotherapy-induced peripheral neuropathy—a common side effect involving nerve damage—in African American patients with early-stage breast cancer. It also involves quality-of-life assessments and questionnaires to evaluate the impact on patients' well-being.

How Is the Trial Designed?

Group I: Arm B (docetaxel) Experimental Treatment 3 Interventions

Patients receive docetaxel IV over 1 hour once every 3 weeks. Treatment repeats every 21 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity. Patients may also receive cyclophosphamide, doxorubicin, trastuzumab, and/or pertuzumab per institution routine care per treating physician's discretion.

Group II: Arm A (paclitaxel) Experimental Treatment 3 Interventions

Patients receive paclitaxel IV over 3 hours once weekly. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may also receive trastuzumab and/or pertuzumab per institution routine care per treating physician's discretion.

Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in European Union as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in Canada as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in Japan as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10093690/

an analysis of 377 breast cancer patients treated with ... Docetaxel is an effective chemotherapy option in patients with locally advanced and/or metastatic breast cancer, including an 'anthracycline refractory' ...

2. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)41184-8/fulltext

Survival outcome and cost-effectiveness with docetaxel ... A randomized controlled trial showed longer overall survival (OS) with docetaxel compared with paclitaxel in metastatic breast cancer patients with prior ...

3. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-022-09196-x

The influence of docetaxel schedule on treatment tolerability ... Weekly docetaxel is associated with a lower risk of neutropenia, febrile neutropenia and neuropathy than the three-weekly docetaxel schedule in metastatic ...

4. cancernetwork.com cancernetwork.com/view/fec-followed-docetaxel-improves-breast-ca-outcomes

FEC Followed by Docetaxel Improves Breast Ca Outcomes The overall survival rate, therefore, was 90.7% vs 86.7% (P = .017), representing a 23% relative risk reduction. Dr. Roche pointed out that both therapies ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0923753419411848

original articles breast cancer Survival outcome and cost ... A randomized controlled trial showed longer overall survival (OS) with docetaxel compared with paclitaxel in metastatic breast cancer patients with prior ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4705087/

Based Chemotherapy in Early Breast Cancer Patients ... Docetaxel-based chemotherapy did not show any significant safety concerns for early breast cancer patients of the Asia-Pacific region.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0959804999001744

Efficacy and safety of docetaxel (Taxotere™) in heavily ... The aim of this investigation was to assess retrospectively docetaxel safety and efficacy in advanced breast cancer patients in a French compassionate use ...

8. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)54331-9/fulltext

Weekly docetaxel (Taxotere®) in patients with metastatic ... Overall response rate was 34% (95% confidential interval (95% CI): 18%–51%). Median survival was 307 days; median progression-free survival was 2.6 months ( ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03671044?term=Docetaxel%20Anhydrous&viewType=Table&rank=5

A Study to Evaluate the Efficacy and Safety of Nanosomal ... This randomized, open-label study is designed to assess the efficacy and safety of Nanosomal Docetaxel Lipid Suspension at the dose of 75 mg/m2 and at the dose ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3798099/

Benefit risk assessment and update on the use of docetaxel in ... Analyzing data from 12,000 women, the EBCTCG has reported an absolute gain of almost 3% in breast cancer mortality associated with the incorporation of taxanes ...