Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00016276 · ClinicalTrials.gov registry record · Phase 3

Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer

A Phase 3 study, sponsored by National Cancer Institute (NCI).

Terminated
Registry status
Phase 3
Development phase
396
Enrollment target

NCT00016276: Clinical Trial Phase 3 study, sponsored by National Cancer Institute (NCI).

NCT00016276 is a Phase 3 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 396 participants. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00016276, a Phase 3 study, was terminated before completion, sponsored by National Cancer Institute (NCI).

TERMINATED
Registry status
Phase 3
Development phase
396 participants
Enrollment target

Study Summary

Randomized phase III trial to compare the effectiveness of combination chemotherapy, surgery, and radiation therapy with or without dexrazoxane and trastuzumab in treating women who have stage IIIA, stage IIIB or stage IV breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if chemotherapy combined with surgery and radiation therapy is more effective with or without dexrazoxane and trastuzumab in treating breast cancer

Interventions

  • DRUG cyclophosphamide
  • DRUG paclitaxel
  • BIOLOGICAL trastuzumab
  • DRUG dexrazoxane hydrochloride
  • DRUG doxorubicin hydrochloride

Trial Details

FieldValue
Enrollment Target 396 participants
Start Date 2001-05
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT00016276

The ClinicalTrials.gov registry entry for NCT00016276 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 396 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.

NCT00016276 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00016276 about?

NCT00016276 is a clinical study titled "Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer". Randomized phase III trial to compare the effectiveness of combination chemotherapy, surgery, and radiation therapy with or without dexrazoxane and trastuzumab in treating women who have stage IIIA, stage IIIB or stage IV breast cancer. Drugs used in chemotherapy use different ways to stop tumor cel...

What is the current status of trial NCT00016276?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 396 participants. The study started on 2001-05.

What interventions are being tested in trial NCT00016276?

The interventions under investigation include: cyclophosphamide (DRUG), paclitaxel (DRUG), trastuzumab (BIOLOGICAL), dexrazoxane hydrochloride (DRUG), doxorubicin hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00016276?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

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

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, the data changelog, or report a data error.