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NCT00068341 · ClinicalTrials.gov registry record · Phase 2
Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer
A Phase 2 study, sponsored by Jonsson Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 74
- Enrollment target
NCT00068341: Completed Phase 2 study, sponsored by Jonsson Comprehensive Cancer Center.
NCT00068341 is a Phase 2 study that has completed, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 74 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00068341, a Phase 2 study, has completed, sponsored by Jonsson Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 74 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, 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. It is not yet known whether docetaxel and carboplatin are more effective with or without trastuzumab in treating breast cancer. PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone before surgery in treating women with locally advanced breast cancer.
Primary Outcome
Objective response rate of patients treated with Taxotere/carboplatin with or without Herceptin preoperatively. Objective response equals the combination of complete response (CR), partial response (PR) and marginal response (MR). Tumor size was assessed by (1) physical examination, (2) mammography and (3) MRI. 5 response groups: complete response (CR), partial response (PR), marginal response (MR), stable disease (SD) \& disease progression (DP). Pathologic response assigned into 2 groups: pCR
Interventions
- DRUG carboplatin
- DRUG docetaxel
- BIOLOGICAL trastuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2003-07 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
What the finished NCT00068341 record still lists
NCT00068341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 3 interventions - of which carboplatin is the first listed.
NCT00068341 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00068341 about?
NCT00068341 is a clinical study titled "Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer". RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, 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 harm...
What is the current status of trial NCT00068341?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2003-07. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00068341?
The interventions under investigation include: carboplatin (DRUG), docetaxel (DRUG), trastuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00068341?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00068341's enrollment target sits among peer trials
74 920th of 2000 higher than 1,077 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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