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Taxane

Docetaxel vs Paclitaxel for Breast Cancer

Phase 2

Waitlist Available

Led By Bryan P Schneider

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must not have received prior taxane or prior/concurrent platinum therapy

Patients must have plans to receive either neoadjuvant or adjuvant: Every 3-week docetaxel x 4-6 cycles OR Weekly paclitaxel x 4 cycles

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at baseline, at end of each cycle, at 6 months and 1 year post registration

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at two different drugs to see how well they reduce chemotherapy-induced nerve damage in African American patients with early to mid-stage breast cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Docetaxel and paclitaxel may cause side effects such as nerve damage leading to numbness or tingling in hands and feet (peripheral neuropathy), allergic reactions, fatigue, muscle aches, low white blood cell count increasing infection risk, nail changes, fluid retention among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am planning to receive specific chemotherapy before or after surgery.

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I do not have nerve damage in my hands or feet.

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I am fully active or can carry out light work.

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I have had cancer before but haven't been treated with taxane, platinum, or vinca alkaloids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline, an end of each cycle, at 6 months and 1 year post registration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at baseline, an end of each cycle, at 6 months and 1 year post registration

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, an end of each cycle, at 6 months and 1 year post registration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants With Grade 2-4 Taxane-Induced Peripheral Neuropathy (TIPN) by Genotype Risk Group in Arm A

Secondary study objectives

Patient-Reported Neuropathy Score Change Between Baseline and End of Treatment by Genotype Risk Group in Patients on Arm A

Percentage of Participants With Dose Reduction Due to Any Reason Between Arm A and Arm B

Percentage of Participants With Dose Reduction Due to TIPN Between Arm A and Arm B

+2 more

Other study objectives

Association between Social economic determinants of health and treatment completion

Association between social determinants of health and FACT-Ntx HRQoL scores

Social economic determinants of health and FACT-Ntx neurotoxicity scores

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (docetaxel)Experimental Treatment3 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 Treatment3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

Docetaxel

1995

Completed Phase 4

~6550