A Study of AC Followed by a Combination of Paclitaxel Plus Trastuzumab or Lapatinib or Both Given Before Surgery to Patients With Operable HER2 Positive Invasive Breast Cancer
Public ClinicalTrials.gov record NCT00486668. 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 of Neoadjuvant Therapy for Patients With Palpable and Operable HER2-Positive Breast Cancer Comparing the Combination of Trastuzumab Plus Lapatinib to Trastuzumab and to Lapatinib Administered With Weekly Paclitaxel Following AC Accompanied by Correlative Science Studies to Identify Predictors of Pathologic Complete Response
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary purpose of this study is to determine whether breast cancer tumors respond (as measured by pathologic complete response: the absence of microscopic evidence of invasive tumor cells in the breast) to combined chemotherapy of AC(doxorubicin and cyclophosphamide) followed by paclitaxel plus trastuzumab or lapatinib or both given before surgery to patients with HER2-positive breast cancer. Trastuzumab will also be given to all patients after surgery. The study will also evaluate the toxic effects of the chemotherapy combination, including effects on the heart, and will determine survival and progression-free survival 5 years after treatment. Also, the study will look at whether there are gene expression profiles in the tumor tissue that can predict pathologic complete response.
Study identification
- NCT ID
- NCT00486668
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 529 participants
Conditions and interventions
Conditions
Interventions
- doxorubicin Drug
- cyclophosphamide Drug
- paclitaxel Drug
- trastuzumab Drug
- lapatinib Drug
Drug
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
- Mar 2017 (Estimated)
- Last update posted
- Jun 6, 2016
2007 – 2017
United States locations
- U.S. sites
- 103
- U.S. states
- 36
- U.S. cities
- 91
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| MBCCOP, Gulf Coast | Mobile | Alabama | 36608 | — |
| Scripps Cancer Center-San Diego | La Jolla | California | 92037 | — |
| University of California, Irvine Medical Center | Long Beach | California | 90801 | — |
| Pacific Shores Medical Group | Long Beach | California | 90813 | — |
| St. Joseph Hospital | Orange | California | 92868 | — |
| Desert Regional Medical Center Comprehensive Cancer Center | Palm Springs | California | 92262 | — |
| Stanford University Medical Center | Palo Alto | California | 94304 | — |
| Sutter Medical Center | Sacramento | California | 95816 | — |
| Kaiser Permanente-San Diego | San Diego | California | 92120 | — |
| Santa Rosa Memorial Hospital | Santa Rosa | California | 95403 | — |
| Kaiser Permanente-Vallejo | Vallejo | California | 94589 | — |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | — |
| Memorial Hospital | Colorado Springs | Colorado | 80909 | — |
| Kaiser Permanente-Franklin | Denver | Colorado | 80205 | — |
| CCOP-Colorado Cancer Research Prog. Inc.(Administrative Only) | Denver | Colorado | 80224 | — |
| Kaiser Permanente Rock Creek | Lafayette | Colorado | 80026 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| Eastern Connecticut Hematology & Oncology Associates | Norwich | Connecticut | 06360 | — |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | — |
| MD Anderson Cancer Center | Orlando | Florida | 32806 | — |
| Phoebe Putney Memorial Hospital | Albany | Georgia | 31701 | — |
| MBCCOP, Medical College of Georgia Research Institute | Augusta | Georgia | 30912 | — |
| University of Hawaii | Honolulu | Hawaii | 96813 | — |
| Kaiser Permanente Hawaii - Moanalua Med Center | Honolulu | Hawaii | 96819 | — |
| Kootenai Cancer Center | Coeur d'Alene | Idaho | 83814 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | — |
| Cancer Institute at Alexian Brothers Hospital Network | Elk Grove | Illinois | 60007 | — |
| Edward Hospital | Naperville | Illinois | 60566 | — |
| Edward Cancer Center Plainfield | Plainfield | Illinois | 60585 | — |
| CCOP, Central Illinois | Springfield | Illinois | 62526 | — |
| CCOP, Carle Cancer Center | Urbana | Illinois | 61801 | — |
| St. Vincent Hospital and Health Care Center | Indianapolis | Indiana | 46260 | — |
| CCOP, Northern Indiana Cancer Research Consortium | South Bend | Indiana | 46601 | — |
| CCOP, Des Moines, IA | Des Moines | Iowa | 52501 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| CCOP, Sioux Community Cancer consortium | Sioux City | Iowa | 51101 | — |
| CCOP, Wichita KS | Wichita | Kansas | 67214 | — |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | — |
| NortonHealtcare Inc. | Louisville | Kentucky | 40202 | — |
| CCOP, Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | — |
| Franklin Square Hospital Center | Baltimore | Maryland | 21237 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| CCOP, Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| CCOP, Grand Rapids Clnical Oncology Program | Grand Rapids | Michigan | 49503 | — |
| CCOP, Kalamazoo, MI | Kalamazoo | Michigan | 49007 | — |
| Michigan State University - Breslin Cancer Center | Lansing | Michigan | 48910 | — |
| CCOP, William Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
| Providence Hospital - Southfield | Southfield | Michigan | 48075-9975 | — |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | — |
| CCOP, Metro-Minnesota | Minneapolis | Minnesota | 55416 | — |
| University of Missouri-Ellis Fischel | Columbia | Missouri | 65203 | — |
| CCOP, Kansas City (Administrative Only) | Kansas City | Missouri | 64131 | — |
| CCOP, Ozark Health Ventures LLC | Springfield | Missouri | 65804 | — |
| Saint Louis UniversityHealth Sciences Center | St Louis | Missouri | 63110 | — |
| CCOP, Heartland Cancer Research | St Louis | Missouri | 63131 | — |
| CCOP, Montana Cancer Consortium | Billings | Montana | 59101 | — |
| CCOP, Missouri Valley Consortium | Omaha | Nebraska | 74136 | — |
| Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | — |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | — |
| New York Oncology Hematology PC-Albany | Albany | New York | 12206 | — |
| Cancer Center at Glens Falls Hospital | Glens Falls | New York | 12801 | — |
| CCOP, Hematology-Oncology Associates of CNY | Syracuse | New York | 13057 | — |
| Alamance Regional Medical Center | Burlington | North Carolina | 27215 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 28302 | — |
| CCOP, Southeast Cancer Control Consortium | Charlotte | North Carolina | 28203 | — |
| Alamance Regional Medical Center - Off site Clinic | Mebane | North Carolina | 27302 | — |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | — |
| Akron City Hospital | Akron | Ohio | 44304 | — |
| Aultman Hospital | Canton | Ohio | 44710 | — |
| Case Western Reserve/University Hospitals-Ireland Cancer Cntr. | Cleveland | Ohio | 44106 | — |
| Ohio State University | Columbus | Ohio | 43017 | — |
| CCOP, Columbus, OH | Columbus | Ohio | 43215 | — |
| CCOP, Dayton, OH | Dayton | Ohio | 45429 | — |
| CCOP, Oklahoma | Tulsa | Oklahoma | 74136 | — |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18105 | — |
| Geisinger Clinic | Danville | Pennsylvania | 17882-2170 | — |
| Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Albert Einstein Healthcare Network | Philadelphia | Pennsylvania | 19141-3098 | — |
| Allegheny General Hospital/Allegheny-Singer Research Institute | Pittsburgh | Pennsylvania | 15212 | — |
| NSABP Foundation, Inc. | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | — |
| Mercy Hospital | Scranton | Pennsylvania | 18501 | — |
| Reading Hospital & Medical Center | West Reading | Pennsylvania | 19612 | — |
| CCOP, Main Line Health | Wynnewood | Pennsylvania | 19096 | — |
| CCOP, Upstate Carolina | Spartanburg | South Carolina | 29303 | — |
| Sanford Cancer Center | Souix Falls | South Dakota | 57104 | — |
| Thompson Cancer Survival Center-Dowell Springs | Knoxville | Tennessee | 37909 | — |
| Joe Arrington Cancer Research & Treatment Center | Lubbock | Texas | 79410 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| MBCCOP, Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
| Puget Sound Oncology Consortium | Seattle | Washington | 98109 | — |
| CCOP, Virginia Mason | Seattle | Washington | 99519 | — |
| CCOP, Northwest | Tacoma | Washington | 83706 | — |
| West Virginia University Hospitals Inc. | Morgantown | West Virginia | 26506-9162 | — |
| Camden-Clark Memorial Hospital | Parkersburg | West Virginia | 26101 | — |
| Wheeling Hospital | Wheeling | West Virginia | 26003 | — |
| CCOP, Marshfield Clinic | Marshfield | Wisconsin | 54449 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
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 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00486668, 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 Jun 6, 2016 · Synced Oct 26, 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 NCT00486668 live on ClinicalTrials.gov.