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NCT00206453 · ClinicalTrials.gov registry record · Phase 2
Extension Neoadjuvant Taxotere: Study of the Effects of Taxotere in Patients With Breast Cancer
A Phase 2 study, sponsored by Baylor Breast Care Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT00206453 is a Phase 2 study that was terminated before completion, run by Baylor Breast Care Center. The registered enrollment target is 25 participants.
The verdict
NCT00206453, a Phase 2 study, was terminated before completion, sponsored by Baylor Breast Care Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
We, the investigators at Baylor Breast Care Cancer, are doing this study to learn how well Taxotere makes tumors become smaller. We are also doing this study to find out how well Taxotere treats the type of breast cancer that some patients have. We are asking patients to take part in this study because they have locally advanced breast cancer. Women with this breast cancer will usually receive chemotherapy medicines to reduce or shrink the cancer before surgery to take out the cancer. If patients choose to take part in this study, they will receive Taxotere and the combination of cyclophosphamide and doxorubicin. These medicines are part of the standard good medical care for this type of breast cancer. They are approved for the treatment of this problem. To help us learn how the patients' cancer responds to these medicines, we will take a small tissue sample (biopsy) of the patients' breast cancer before beginning treatment, one day after the first dose of treatment, once each week for the first three weeks of treatment, and when surgery is done as part of treatment for their cancer. These samples will be collected also to look at the biology of the patients' cancer. We will also use a new method called cDNA array technology, which lets us look at thousands of genes (coding information inside the cancer cell) at once. By looking at different genes in the breast cancer, we may learn important information about which cancers will respond to a chemotherapy medicine. We hope to learn if there are different gene patterns in patients whose tumors shrink or do not shrink with this chemotherapy medicine. This information may help us, in the future, to choose the right medicines for women with breast cancer so that they have the highest chance of their cancer shrinking with chemotherapy medicine. We cannot and do not know if patients will benefit if they take part in this study.
Interventions
- DRUG Taxotere
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2002-01 |
| Est. Completion | 2005-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00206453
The ClinicalTrials.gov registry entry for NCT00206453 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor Breast Care Center, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Taxotere is the first listed.
NCT00206453 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00206453 about?
NCT00206453 is a clinical study titled "Extension Neoadjuvant Taxotere: Study of the Effects of Taxotere in Patients With Breast Cancer". We, the investigators at Baylor Breast Care Cancer, are doing this study to learn how well Taxotere makes tumors become smaller. We are also doing this study to find out how well Taxotere treats the type of breast cancer that some patients have. We are asking patients to take part in this study beca...
What is the current status of trial NCT00206453?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2002-01. Estimated completion is 2005-01.
What interventions are being tested in trial NCT00206453?
The interventions under investigation include: Taxotere (DRUG).
Who is sponsoring clinical trial NCT00206453?
This trial is sponsored by Baylor Breast Care Center, which has 15 total clinical trials registered on ClinicalTrials.gov.
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