249 Participants Needed

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 GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

BP

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.
See 10 more

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?
2Treatment groups
Experimental Treatment
Group I: Arm B (docetaxel)Experimental Treatment3 Interventions
Group II: Arm A (paclitaxel)Experimental Treatment3 Interventions

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

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Approved in United States as Taxotere for:
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Approved in European Union as Taxotere for:
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Approved in Canada as Taxotere for:
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Approved in Japan as Taxotere for:

Find a Clinic Near You

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+
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