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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 be women with a known stage I-III invasive breast cancer diagnosis. Registration must occur within 84 days from the date of diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years post-registration

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 a woman diagnosed with stage I-III breast cancer within the last 84 days.

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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.

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I am using or will use effective birth control or abstain from sex during the study.

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I am willing and able to agree to the study's procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years post-registration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years post-registration

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years post-registration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Validation of a prior germline predictor of paclitaxel-induced peripheral neuropathy (Arm A)

Secondary outcome measures

Financial toxicity between both arms

Grade 2-4 taxane-induced peripheral neuropathy (TIPN)

Health-related quality of life (HRQoL) between both arms

+3 more

Other outcome measures

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

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

~5380

Docetaxel

1995

Completed Phase 4

~5620

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor

116 Previous Clinical Trials

176,673 Total Patients Enrolled

4 Trials studying Breast Cancer

3,528 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,904 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Bryan P SchneiderPrincipal InvestigatorECOG-ACRIN Cancer Research Group

3 Previous Clinical Trials

1,091 Total Patients Enrolled

Media Library

Docetaxel (Taxane) Clinical Trial Eligibility Overview. Trial Name: NCT04001829 — Phase 2

Breast Cancer Research Study Groups: Arm A (paclitaxel), Arm B (docetaxel)

Breast Cancer Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT04001829 — Phase 2

Docetaxel (Taxane) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04001829 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How widely is this investigation being conducted?

"This trial is currently recruiting from a total of 100 different centres, including Aria Health-Torresdale Campus in Philadelphia, Aurora Cancer Care-Southern Lakes VLCC in Burlington, and 21st Century Oncology-Henderson in Henderson."

Answered by AI

Have other research projects employed Docetaxel as a component?

"Currently, 1088 trials investigating the efficacy of Docetaxel are in progress. Of those active studies, 317 have reached Phase 3 status. Although Shanghai is by far the most popular area for these trails to be conducted (58781 locations), other areas worldwide have launched investigations as well."

Answered by AI

To what degree does Docetaxel pose a risk to patients?

"Considering the Phase 2 status of Docetaxel, there is sufficient clinical data to validate its safety but none to demonstrate efficacy; thus it was assigned a score of 2."

Answered by AI

What maladies is Docetaxel employed to remedy?

"Docetaxel is the go-to option for neoplasm metastasis, and can also be beneficial in treating a variety of other medical conditions such as soft tissue sarcoma (STS), locally advanced non-small cell lung cancer, or even metastatic bladder cancer."

Answered by AI

How many participants are being included in this clinical trial?

"This medical trial has closed its recruitment window. The study was initially listed on June 27th, 2019 and the last update occurred April 14th, 2022. Currently, there are 2432 studies recruiting participants with breast conditions and 1088 trials accepting volunteers for Docetaxel research."

Answered by AI

Is the enrollment process for this study still open?

"The data found on clinicaltrials.gov displays that this medical trial is not open for enrollment any longer, as the last update was in April of 2022 and it first began recruiting patients back in June 2019. While recruitment has ceased, there are still 3520 other trials searching for volunteers across the globe."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Docetaxel or Paclitaxel in Reducing Chemotherapy-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer

2019. "Docetaxel or Paclitaxel in Reducing Chemotherapy-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04001829.

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