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NCT00004888 · ClinicalTrials.gov registry record · Phase 2
Combination Chemotherapy With or Without Trastuzumab in Treating Women With Metastatic Breast Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
NCT00004888: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00004888 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 84 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00004888, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
Study Summary
Phase II trial to study the effectiveness of combination chemotherapy with or without trastuzumab in treating women who have metastatic breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
Primary Outcome
This table summarizes the cardiotoxicity events of different grades. Grade 1 is a decline of left ventricular ejection fraction(LVEF) \>=10% but \<20% of baseline value. Grade 2 is LVEF below LLN (50%) or decline of LVEF \>=20% of baseline value. Grade 3 is congestive heart failure responsive to treatment. Please note that only a subset of patients reported cardiotoxic events so the totals will not add up to the total number of participants.
Interventions
- OTHER laboratory biomarker analysis
- DRUG docetaxel
- BIOLOGICAL trastuzumab
- DRUG pegylated liposomal doxorubicin hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2001-01 |
| Est. Completion | 2009-05 |
| Phase | Phase 2 |
What the finished NCT00004888 record still lists
NCT00004888 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT00004888 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00004888 about?
NCT00004888 is a clinical study titled "Combination Chemotherapy With or Without Trastuzumab in Treating Women With Metastatic Breast Cancer". Phase II trial to study the effectiveness of combination chemotherapy with or without trastuzumab in treating women who have metastatic breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzuma...
What is the current status of trial NCT00004888?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2001-01. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00004888?
The interventions under investigation include: laboratory biomarker analysis (OTHER), docetaxel (DRUG), trastuzumab (BIOLOGICAL), pegylated liposomal doxorubicin hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00004888?
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 NCT00004888's enrollment target sits among peer trials
84 822nd of 2000 higher than 1,173 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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