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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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Compared in the Herceptin and no Herceptin groups and in the dexrazoxane versus no dexrazoxane groups using a chi-square test and a two-sample t test, respectively.
Interventions
- DRUG cyclophosphamide
- DRUG paclitaxel
- BIOLOGICAL trastuzumab
- DRUG dexrazoxane hydrochloride
- DRUG doxorubicin hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 396 participants |
| Start Date | 2001-05 |
| Phase | Phase 3 |
Why NCT00016276 stopped before completion
NCT00016276 is an interventional study that assigns participants to a tested intervention. The registered 396 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00016276 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00016276's enrollment target sits among peer trials
396 964th of 2000 higher than 1,036 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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