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

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Study completion moved earlier from Aug 31, 2027 to Apr 5, 2027 Show 5 more changesShow less
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study description revised
    • Site details revised at 36 of 482 sites
    • Publications: details revised at 1 of 1 entry
  2. Trial sites reduced: 485 → 482 locationsv31 Show 4 more changesShow less
    • Study completion pushed from Mar 31, 2027 to Aug 31, 2027
    • Eligibility criteria expanded, about 65 words
    • Study description expanded, about 28 words
    • Study title expanded, about 3 words
  3. 8 versions Re-verified since Nov 11, 2025, no change to tracked fieldsv23-v30
  4. Site details revised at 1 of 485 sitesv22
  5. Re-verified, no change to tracked fieldsv21
Show 19 earlier versionsHide 19 earlier versions
  1. Secondary endpoints: details revised at 1 of 5 entriesv20
  2. Results first posted: Jun 12, 2024
    • Primary endpoint revised
    • Secondary endpoints revised (5)
    v19
  3. Primary endpoint revisedv18 Show 6 more changesShow less
    • Primary completion date changed from estimate of Jun 30, 2024 to Sep 19, 2023
    • Study completion date: Sep 1, 2024 to Mar 31, 2027
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: 6 to 5
    • Study description shortened, about 2 words
    • Study title shortened, about 3 words
  4. Re-verified, no change to tracked fieldsv17
  5. Primary completion date: Dec 31, 2023 to Jun 30, 2024v16
  6. Start date: Jun 27, 2019 to Aug 9, 2019v15
  7. Primary completion date: Sep 1, 2023 to Dec 31, 2023
    • Study completion date: Sep 1, 2023 to Sep 1, 2024
    v14
  8. Primary and study completion dates: Jun 1, 2023 to Sep 1, 2023v13
  9. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 240 to confirmed 249
    • Site details revised at 485 of 485 sites
    v12
  10. Site details revised at 3 of 485 sitesv11
  11. Study sites: 476 to 485v10
  12. Site details revised at 45 of 476 sitesv9
  13. Site details revised at 21 of 476 sitesv8
  14. Study sites: 475 to 476v7
  15. Study sites: 469 to 475v6
  16. Study sites: 407 to 469v5
  17. Study sites: 83 to 407v4
  18. Re-verified, no change to tracked fieldsv3
  19. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 83
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase II trial studies how well docetaxel or paclitaxel work in reducing chemotherapy-induced peripheral neuropathy in African American patients with stages I-III breast cancer. Drugs used in chemotherapy, such as docetaxel and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving docetaxel or paclitaxel may work better than other methods in reducing chemotherapy-induced peripheral neuropathy in patients with breast cancer.
Trial Details
NCT Number NCT04001829
Lead Sponsor ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8 +13 more
Enrollment 249 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov