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NCT00635050 · ClinicalTrials.gov registry record · Phase 2
Therapy for Locally Advanced Breast Cancer Using Doxil, Paclitaxel, and Cyclophosphamide With Avastin
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT00635050 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 32 participants.
The verdict
NCT00635050, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
This study will evaluate the rate of pathological complete response (pCR) to the sequential therapy of Doxil, paclitaxel, and cyclophosphamide with concurrent Avastin for patients with locally advanced invasive (T2,T3, Nany, M0) breast carcinoma. Also, the study will evaluate the clinical and subclinical cardiotoxic effect(s) of this regimen, assess how feasible and safe the study is. Survival without any progression of disease will also be calculated. A regimen of chemotherapy will be given to replicate the high rate of pCR seen with conventional chemotherapy in patients with locally advanced breast cancer. Doxil will substitute the normally given doxorubicin. It is expected that the low effect or minimal effect of Doxil on cardiac function will minimize any additional risk of cardiotoxicity from Avastin. It is expected that clinical and subclinical rates of cardiotoxicity will be very low at the total doses to be given in this clinical trial.
Interventions
- DRUG Doxil, Paclitaxel, Cyclophosphamide, Avastin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2008-03 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00635050
The ClinicalTrials.gov registry entry for NCT00635050 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Doxil, Paclitaxel, Cyclophosphamide, Avastin is the first listed.
NCT00635050 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00635050 about?
NCT00635050 is a clinical study titled "Therapy for Locally Advanced Breast Cancer Using Doxil, Paclitaxel, and Cyclophosphamide With Avastin". This study will evaluate the rate of pathological complete response (pCR) to the sequential therapy of Doxil, paclitaxel, and cyclophosphamide with concurrent Avastin for patients with locally advanced invasive (T2,T3, Nany, M0) breast carcinoma. Also, the study will evaluate the clinical and subcli...
What is the current status of trial NCT00635050?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2008-03. Estimated completion is 2015-06.
What interventions are being tested in trial NCT00635050?
The interventions under investigation include: Doxil, Paclitaxel, Cyclophosphamide, Avastin (DRUG).
Who is sponsoring clinical trial NCT00635050?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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