Taxane

Docetaxel for Breast Cancer

Kennedy Health Systems-Cancer Center, Sewell, NJ

Targeting 21 different conditionsDocetaxel +3 morePhase 2Waitlist AvailableLed by Bryan P SchneiderResearch 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 with a history of other cancers are eligible if they have not received prior taxane or platinum or vinca alkaloid therapy

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

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 3 years post-registration

Awards & highlights

No Placebo-Only Group

Approved for 10 Other Conditions

All Individual Drugs Already Approved

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.

Eligible Conditions

Breast Cancer

Eligibility Criteria

Inclusion Criteria

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

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You can participate if you have had other types of cancer before, as long as you have not been treated with certain types of chemotherapy drugs called taxane, platinum, or vinca alkaloids.

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You have not received certain types of chemotherapy drugs called taxane or platinum therapy in the past.

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You should not have any existing nerve problems in your arms or legs.

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

Awards & Highlights

No Placebo-Only Group

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

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

FDA approved

Docetaxel

FDA approved

0 / 3Eligibility criteria met

Find a site

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor

111 Previous Clinical Trials

175,235 Total Patients Enrolled

4 Trials studying Breast Cancer

3,528 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,402 Previous Clinical Trials

41,225,092 Total Patients Enrolled

930 Trials studying Breast Cancer

1,540,025 Patients Enrolled for Breast Cancer

Bryan P SchneiderPrincipal Investigator

ECOG-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.