deltatrials
Completed PHASE3 NCT00003440

Paclitaxel With or Without Trastuzumab in Treating Patients With or Without HER-2/Neu Breast Cancer That is Inoperable, Recurrent, or Metastatic

A Phase III Study of Paclitaxel Via Weekly 1 Hour Infusion Versus Standard 3 Hour Infusion Every 3 Weeks With Herceptin (Trastuzumab) (NSC #688097) in the Treatment of Patients With/Without HER-2/Neu-Overexpressing Metastatic Breast Cancer

Sponsor: National Cancer Institute (NCI)

Conditions HER2-negative Breast Cancer HER2-positive Breast Cancer Recurrent Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer
Interventions laboratory biomarker analysis paclitaxel quality-of-life assessment trastuzumab
Updated 6 times since 2017 Last updated: Jun 3, 2013 Started: Jul 31, 1998 Primary completion: Jul 31, 2004

Listed as NCT00003440, this PHASE3 trial focuses on HER2-negative Breast Cancer and HER2-positive Breast Cancer and remains completed. Sponsored by National Cancer Institute (NCI), it has been updated 6 times since 1998, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Change History

6 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

  5. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE3

▶ Show 1 earlier version

  1. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

Jul 1998

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
Data source: National Cancer Institute (NCI)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

  • • Chicago, United States