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NCT04001829 · ClinicalTrials.gov registry record · Phase 2

Taxane and Taxane-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer

A Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by ECOG-ACRIN Cancer Research Group.

Active
Registry status
Phase 2
Development phase
249
Enrollment target
20
Study locations

NCT04001829 is a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8 that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 249 participants, below the 302-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (18% lower). The trial reports 20 study locations across 5 states.

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The verdict

NCT04001829, a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
249 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIB Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8

Interventions

  • DRUG Docetaxel
  • OTHER Quality-of-Life Assessment
  • DRUG Paclitaxel
  • OTHER Questionnaire Administration

Study Locations (20)

Alaska

  • Anchorage Associates in Radiation Medicine - Anchorage
  • Anchorage Radiation Therapy Center - Anchorage
  • Alaska Breast Care and Surgery LLC - Anchorage
  • Alaska Oncology and Hematology LLC - Anchorage
  • Alaska Women's Cancer Care - Anchorage
  • Anchorage Oncology Centre - Anchorage
  • Katmai Oncology Group - Anchorage
  • Providence Alaska Medical Center - Anchorage
  • Fairbanks Memorial Hospital - Fairbanks

California

  • PCR Oncology - Arroyo Grande
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
  • Epic Care-Dublin - Dublin
  • Bay Area Breast Surgeons Inc - Emeryville
  • Epic Care Partners in Cancer Care - Emeryville
  • Contra Costa Regional Medical Center - Martinez
  • Alta Bates Summit Medical Center - Summit Campus - Oakland

Arkansas

  • Mercy Hospital Fort Smith - Fort Smith
  • Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro

Alabama

  • University of Alabama at Birmingham Cancer Center - Birmingham

Arizona

  • Kingman Regional Medical Center - Kingman

Trial Details

FieldValue
Enrollment Target 249 participants
Start Date 2019-08-09
Est. Completion 2027-03-31
Phase Phase 2

Sponsor

ECOG-ACRIN Cancer Research Group

75 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04001829

The ClinicalTrials.gov registry entry for NCT04001829 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 249 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 302-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (18% lower). The listed sponsor is ECOG-ACRIN Cancer Research Group, which has 75 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Docetaxel is the first listed.

NCT04001829 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Alaska, California, Arkansas.

Frequently Asked Questions

What is clinical trial NCT04001829 about?

NCT04001829 is a clinical study titled "Taxane and Taxane-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer". 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 inv...

What is the current status of trial NCT04001829?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 249 participants. The study started on 2019-08-09. Estimated completion is 2027-03-31.

What conditions does trial NCT04001829 study?

This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8.

What interventions are being tested in trial NCT04001829?

The interventions under investigation include: Docetaxel (DRUG), Quality-of-Life Assessment (OTHER), Paclitaxel (DRUG), Questionnaire Administration (OTHER).

Who is sponsoring clinical trial NCT04001829?

This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04001829 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.