Docetaxel vs Paclitaxel for Breast Cancer

Recruiting at 486 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: ECOG-ACRIN Cancer Research Group

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

249 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies whether a prior germline predictor of taxane-induced peripheral neuropathy (TIPN) can help identify a subgroup of patients who are at higher risk of chemotherapy-induced peripheral neuropathy in African American patients with stages I-III breast cancer. The study also investigates whether docetaxel maybe work better than paclitaxel with regard to TIPN rate/severity and dose reductions.

Research Team

Bryan P Schneider

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+