Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery
Public ClinicalTrials.gov record NCT00513292. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Phase III Trial Comparing a Neoadjuvant Regimen of FEC-75 Followed by Paclitaxel Plus Trastuzumab With a Neoadjuvant Regimen of Paclitaxel Plus Trastuzumab Followed by FEC-75 Plus Trastuzumab in Patients With HER-2 Positive Operable Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized phase III trial is studying giving fluorouracil together with epirubicin and cyclophosphamide followed by paclitaxel and trastuzumab to see how well it works compared with giving paclitaxel together with trastuzumab followed by fluorouracil, epirubicin, cyclophosphamide, and trastuzumab in treating women with palpable breast cancer that can be removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether it is more effective to give combination chemotherapy before or after treatment with paclitaxel plus trastuzumab.
Study identification
- NCT ID
- NCT00513292
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 280 participants
Conditions and interventions
Conditions
Interventions
- Cyclophosphamide Drug
- Epirubicin Hydrochloride Drug
- Laboratory Biomarker Analysis Other
- Paclitaxel Drug
- Therapeutic Conventional Surgery Procedure
- Trastuzumab Biological
Drug · Other · Procedure + 1 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2007 (Type not available)
- Primary completion
- Jun 2012 (Actual)
- Completion
- Feb 21, 2013 (Actual)
- Last update posted
- Jan 23, 2019
2007 – 2013
United States locations
- U.S. sites
- 114
- U.S. states
- 29
- U.S. cities
- 86
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama Mitchell Cancer Institute | Mobile | Alabama | 36688 | — |
| Eden Hospital Medical Center | Castro Valley | California | 94546 | — |
| Marin Cancer Care Inc | Greenbrae | California | 94904 | — |
| Saint Rose Hospital | Hayward | California | 94545 | — |
| Valley Care Health System - Pleasanton | Pleasanton | California | 94588 | — |
| Valley Medical Oncology Consultants | Pleasanton | California | 94588 | — |
| Morton Plant Hospital | Clearwater | Florida | 33756 | — |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | — |
| Lakeland Regional Cancer Center | Lakeland | Florida | 33805 | — |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | — |
| Presence Resurrection Medical Center | Chicago | Illinois | 60631 | — |
| Saint Francis Hospital and Health Centers | Beech Grove | Indiana | 46107 | — |
| Franciscan Saint Francis Health-Indianapolis | Indianapolis | Indiana | 46237 | — |
| Reid Hospital and Health Care Services | Richmond | Indiana | 47374 | — |
| Siouxland Regional Cancer Center | Sioux City | Iowa | 51101 | — |
| Mercy Medical Center-Sioux City | Sioux City | Iowa | 51104 | — |
| Saint Luke's Regional Medical Center | Sioux City | Iowa | 51104 | — |
| Cancer Center of Kansas - Chanute | Chanute | Kansas | 66720 | — |
| Cancer Center of Kansas - Dodge City | Dodge City | Kansas | 67801 | — |
| Cancer Center of Kansas - El Dorado | El Dorado | Kansas | 67042 | — |
| Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | 66701 | — |
| Cancer Center of Kansas-Independence | Independence | Kansas | 67301 | — |
| Cancer Center of Kansas-Kingman | Kingman | Kansas | 67068 | — |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | — |
| Cancer Center of Kansas-Liberal | Liberal | Kansas | 67901 | — |
| Cancer Center of Kansas - Newton | Newton | Kansas | 67114 | — |
| Cancer Center of Kansas - Parsons | Parsons | Kansas | 67357 | — |
| Cancer Center of Kansas - Pratt | Pratt | Kansas | 67124 | — |
| Cancer Center of Kansas - Salina | Salina | Kansas | 67401 | — |
| Cancer Center of Kansas - Wellington | Wellington | Kansas | 67152 | — |
| Associates In Womens Health | Wichita | Kansas | 67208 | — |
| Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas | 67208 | — |
| Cancer Center of Kansas - Main Office | Wichita | Kansas | 67214 | — |
| Via Christi Regional Medical Center | Wichita | Kansas | 67214 | — |
| Wesley Medical Center | Wichita | Kansas | 67214 | — |
| Wichita CCOP | Wichita | Kansas | 67214 | — |
| Cancer Center of Kansas - Winfield | Winfield | Kansas | 67156 | — |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | — |
| The James Graham Brown Cancer Center at University of Louisville | Louisville | Kentucky | 40202 | — |
| Unspecified Site | Rockville | Maryland | 20852 | — |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | — |
| Essentia Health Cancer Center | Duluth | Minnesota | 55805 | — |
| Essentia Health Saint Mary's Medical Center | Duluth | Minnesota | 55805 | — |
| Miller-Dwan Hospital | Duluth | Minnesota | 55805 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Singing River Hospital | Pascagoula | Mississippi | 39581 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Nevada Cancer Research Foundation CCOP | Las Vegas | Nevada | 89106 | — |
| Sunrise Hospital and Medical Center | Las Vegas | Nevada | 89109 | — |
| Portsmouth Regional Hospital | Portsmouth | New Hampshire | 03802 | — |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | — |
| UMDNJ - New Jersey Medical School | Newark | New Jersey | 07103 | — |
| Saint Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | — |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | — |
| University of New Mexico | Albuquerque | New Mexico | 87106 | — |
| Presbyterian Kaseman Hospital | Albuquerque | New Mexico | 87110 | — |
| Orange Regional Medical Center | Middletown | New York | 10940 | — |
| MidHudson Regional Hospital of Westchester Medical Center | Poughkeepsie | New York | 12601 | — |
| Staten Island University Hospital | Staten Island | New York | 10305 | — |
| Hope Women's Cancer Centers-Asheville | Asheville | North Carolina | 28816 | — |
| Wayne Memorial Hospital | Goldsboro | North Carolina | 27534 | — |
| Mary Rutan Hospital | Bellefontaine | Ohio | 43311 | — |
| Aultman Health Foundation | Canton | Ohio | 44710 | — |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | — |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | — |
| Columbus CCOP | Columbus | Ohio | 43215 | — |
| Grant Medical Center | Columbus | Ohio | 43215 | — |
| Mount Carmel Health Center West | Columbus | Ohio | 43222 | — |
| Doctors Hospital | Columbus | Ohio | 43228 | — |
| Grandview Hospital | Dayton | Ohio | 45405 | — |
| Good Samaritan Hospital - Dayton | Dayton | Ohio | 45406 | — |
| Miami Valley Hospital | Dayton | Ohio | 45409 | — |
| Samaritan North Health Center | Dayton | Ohio | 45415 | — |
| Dayton CCOP | Dayton | Ohio | 45420 | — |
| Veteran Affairs Medical Center | Dayton | Ohio | 45428 | — |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | — |
| Blanchard Valley Hospital | Findlay | Ohio | 45840 | — |
| Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | — |
| Wayne Hospital | Greenville | Ohio | 45331 | — |
| Kettering Medical Center | Kettering | Ohio | 45429 | — |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | — |
| Marietta Memorial Hospital | Marietta | Ohio | 45750 | — |
| Knox Community Hospital | Mount Vernon | Ohio | 43050 | — |
| Licking Memorial Hospital | Newark | Ohio | 43055 | — |
| Southern Ohio Medical Center | Portsmouth | Ohio | 45662 | — |
| Springfield Regional Medical Center | Springfield | Ohio | 45505 | — |
| Upper Valley Medical Center | Troy | Ohio | 45373 | — |
| Saint Ann's Hospital | Westerville | Ohio | 43081 | — |
| Clinton Memorial Hospital | Wilmington | Ohio | 45177 | — |
| Greene Memorial Hospital | Xenia | Ohio | 45385 | — |
| Genesis HealthCare System | Zanesville | Ohio | 43701 | — |
| Cancer Centers of Southwest Oklahoma Research | Lawton | Oklahoma | 73505 | — |
| Saint Luke's University Hospital-Bethlehem Campus | Bethlehem | Pennsylvania | 18015 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| University of Tennessee - Knoxville | Knoxville | Tennessee | 37920 | — |
| Nashville Breast Center | Nashville | Tennessee | 37203 | — |
| Meharry Medical College | Nashville | Tennessee | 37208 | — |
| The Don and Sybil Harrington Cancer Center | Amarillo | Texas | 79106 | — |
| Parkland Memorial Hospital | Dallas | Texas | 75235 | — |
| Zale Lipshy University Hospital | Dallas | Texas | 75235 | — |
| Clements University Hospital | Dallas | Texas | 75390 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
| M D Anderson Cancer Center | Houston | Texas | 77030 | — |
| Doctor's Hospital of Laredo | Laredo | Texas | 78041 | — |
| Covenant Medical Center-Lakeside | Lubbock | Texas | 79410 | — |
| Danville Regional Medical Center | Danville | Virginia | 24541 | — |
| Sentara Port Warwick | Newport News | Virginia | 23606 | — |
| Swedish Medical Center-First Hill | Seattle | Washington | 98122-4307 | — |
| Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | — |
| Oconomowoc Memorial Hospital-ProHealth Care Inc | Oconomowoc | Wisconsin | 53066-3896 | — |
| Waukesha Memorial Hospital | Waukesha | Wisconsin | 53188 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00513292, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 23, 2019 · Synced Oct 25, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00513292 live on ClinicalTrials.gov.