Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00455533 · ClinicalTrials.gov registry record · Phase 2
Study to Assess Effectiveness of Giving Combination of Standard Chemotherapy Drugs Versus Combination of Standard Chemotherapy and New Drug Ixabepilone When Given Before Surgical Removal of Early Stage Breast Cancer
A Phase 2 study of Breast Cancer, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 384
- Enrollment target
- 20
- Study locations
NCT00455533: Completed Phase 2 study of Breast Cancer, sponsored by Bristol-Myers Squibb.
NCT00455533 is a Phase 2 study of Breast Cancer that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 384 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00455533, a Phase 2 study of Breast Cancer, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 384 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study will evaluate the effectiveness of ixabepilone when given after doxorubicin plus cyclophosphamide (AC) compared to standard treatment of paclitaxel given after doxorubicin plus cyclophosphamide in patients with early stage breast cancer. In addition the study will verify predefined biomarkers as well as discover new biomarkers that could identify patients who are more likely to respond to ixabepilone than standard paclitaxel based therapy.
Primary Outcome
The pCR was defined as no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of ductal carcinoma in situ (DCIS) in the breast.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Paclitaxel
- DRUG Ixabepilone
Study Locations (20)
Other
- Local Institution - Salzburg
- Local Institution - Vienna
- Local Institution - Bordeaux
- Local Institution - Saint-Herblain
- Local Institution - Düsseldorf
- Local Institution - Erlangen
Florida
- Northwest Oncology & Hematology Associates - Coral Spring
- Florida Cancer Research Institute - Davie
- Medical Specialists Of Palm Beaches - Lake Worth
- Moffitt Cancer Center - Tampa
Buenos Aires
- Local Institution - Buenos Aires
- Local Institution - Buenos Aires
- Local Institution - Capital Federal
- Local Institution - Capital Federal
Washington
- Virginia Mason Medical Center - Seattle
- Providence Cancer Center - Spokane
California
- Comprehensive Cancer Center - Palm Springs
Kentucky
- University Medical Center, Inc - Louisville
New Mexico
- University Of New Mexico Cancer Center - Albuquerque
New York
- Albert Einstein Cancer Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 384 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-12 |
| Phase | Phase 2 |
What the finished NCT00455533 record still lists
NCT00455533 is an interventional study that assigns participants to a tested intervention. The registered 384 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT00455533 names 20 study sites across 8 states, led by Other, Florida, Buenos Aires.
Frequently Asked Questions
What is clinical trial NCT00455533 about?
NCT00455533 is a clinical study titled "Study to Assess Effectiveness of Giving Combination of Standard Chemotherapy Drugs Versus Combination of Standard Chemotherapy and New Drug Ixabepilone When Given Before Surgical Removal of Early Stage Breast Cancer". The study will evaluate the effectiveness of ixabepilone when given after doxorubicin plus cyclophosphamide (AC) compared to standard treatment of paclitaxel given after doxorubicin plus cyclophosphamide in patients with early stage breast cancer. In addition the study will verify predefined biomark...
What is the current status of trial NCT00455533?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 384 participants. The study started on 2007-10. Estimated completion is 2009-12.
What conditions does trial NCT00455533 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT00455533?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Paclitaxel (DRUG), Ixabepilone (DRUG).
Who is sponsoring clinical trial NCT00455533?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00455533 being conducted?
This trial has 20 study locations across California, Florida, Kentucky, New Mexico, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00455533's enrollment target sits among peer trials
384 249th of 1224 higher than 976 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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
-
Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC
RECRUITING · Phase 2
-
The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer
RECRUITING · Phase 2
-
Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC
RECRUITING · Phase 2
-
Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial
RECRUITING · Phase 2
-
Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score
RECRUITING · Phase 2
-
Precision Medicine in Action: Phase II Trial of Response Adaptive Ablative Pre-operative SPBI (RAPS) and Non-operative Sentinel Lymph Node Biopsy in Patients With Early-stage ER+ Breast Cancer: RAPS Trial
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06277661 · 384 participants · NA
The Mom and Infant Outcomes (MOMI) Study
- NCT06372964 · 384 participants · Phase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
- NCT06501040 · 384 participants · NA
Increasing Knowledge and Interest in Cancer Clinical Trials
- NCT06566703 · 384 participants · NA
Testing ANSOS for Efficacy in Multi-Tribal Urban Communities
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia