ClinicalTrials.gov record
A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer
ClinicalTrials.gov ID: NCT01358877
Public ClinicalTrials.gov record NCT01358877. 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.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).
Study identification
- NCT ID
- NCT01358877
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 4,804 participants
Conditions and interventions
Conditions
Interventions
- 5-Fluorouracil Drug
- Carboplatin Drug
- Cyclophosphamide Drug
- Docetaxel Drug
- Doxorubicin Drug
- Epirubicin Drug
- Paclitaxel Drug
- Pertuzumab Drug
- Placebo Drug
- Trastuzumab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- 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
- Nov 8, 2011 (Actual)
- Primary completion
- Dec 19, 2016 (Actual)
- Completion
- Nov 28, 2024 (Actual)
- Last update posted
- Nov 28, 2025
2011 – 2024
United States locations
- U.S. sites
- 114
- U.S. states
- 36
- U.S. cities
- 95
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HonorHealth Research Institute ? Bisgrove | Scottsdale | Arizona | 85258 | — |
| Providence Regional Medical Center | Everett | California | 98208 | — |
| Marin Cancer Care Inc | Greenbrae | California | 94904 | — |
| Kaiser Permanente - Hayward | Hayward | California | 94545 | — |
| UCSD Moores Cancer Center | La Jolla | California | 92093 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Kaiser Permanente - Oakland | Oakland | California | 94611 | — |
| Kaiser Permanente - Roseville | Roseville | California | 95661 | — |
| Sutter Cancer Center | Sacramento | California | 95816 | — |
| Kaiser Permanente Sacramento Medical Center | Sacramento | California | 95825 | — |
| Southern California Kaiser Permanente | San Diego | California | 92108 | — |
| K. Permanente - San Fransisco | San Francisco | California | 94115 | — |
| K. Permanente - San Jose | San Jose | California | 95119 | — |
| K. Permanente - Santa Clara | Santa Clara | California | 95051 | — |
| K. Permanente - S. San Fran | South San Francisco | California | 94080 | — |
| Kaiser Permanente | Vallejo | California | 94589 | — |
| K. Permanente - Walnut Creek | Walnut Creek | California | 94596 | — |
| Rocky Mountain Cancer Center - Denver | Denver | Colorado | 80220 | — |
| Lutheran Hematology &Oncology | Wheat Ridge | Colorado | 80033 | — |
| Eastern Ct Hema/Onco Assoc | Norwich | Connecticut | 06360 | — |
| Washington Cancer Institute at MedStar Washington Hospital Center. | Washington D.C. | District of Columbia | 20010 | — |
| Georgetown U | Washington D.C. | District of Columbia | 20057 | — |
| Florida Cancer Specialists | Fort Myers | Florida | 33916 | — |
| Memorial Cancer Institute | Hollywood | Florida | 33021 | — |
| Mayo Clinic-Jacksonville | Jacksonville | Florida | 32224 | — |
| Cancer Specialists | Jacksonville | Florida | 32256 | — |
| Ocala Oncology Center | Ocala | Florida | 34474 | — |
| Memorial Breast Cancer Center | Pembroke Pines | Florida | 33028 | — |
| Hematology Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida | 34952 | — |
| Florida Cancer Specialists | St. Petersburg | Florida | 33705 | — |
| Florida Cancer Specialists, Research Department | West Palm Beach | Florida | 33401 | — |
| Phoebe Putney Memorial Hospital | Albany | Georgia | 31701 | — |
| Georgia Cancer Specialists | Atlanta | Georgia | 30341 | — |
| Northwest Georgia Oncology Centers PC - Marietta | Marietta | Georgia | 30060 | — |
| Kootenai Cancer Center | Post Falls | Idaho | 83854 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Uni of Chicago | Chicago | Illinois | 60637 | — |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | — |
| Loyola University Med Center | Maywood | Illinois | 60153 | — |
| Edward Cancer Center Naperville | Naperville | Illinois | 60540 | — |
| Illinois Cancer Care | Peoria | Illinois | 61615-7828 | — |
| Edward Cancer Center Plainfield | Plainfield | Illinois | 60585 | — |
| Quincy Medical Group | Quincy | Illinois | 62301 | — |
| Carle Foundation | Urbana | Illinois | 61801 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Cancer Center of Kansas | Wichita | Kansas | 67214-3728 | — |
| Cancer Center of Acadiana at Lafayette General | Lafayette | Louisiana | 70503 | — |
| Cancer Care of Maine | Bangor | Maine | 04401 | — |
| New England Cancer Specialists | Scarborough | Maine | 04074 | — |
| Mercy Medical Center | Baltimore | Maryland | 21202 | — |
| Weinberg CA Inst Franklin Sq | Baltimore | Maryland | 21237 | — |
| Maryland Oncology & Hematology, PA | Bethesda | Maryland | 20817 | — |
| Massachusetts General Hospital. | Boston | Massachusetts | 02114 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Beth Israel Deac Med Ctr | Boston | Massachusetts | 02215 | — |
| Dana Farber Can Ins | Boston | Massachusetts | 02215 | — |
| Berkshire Hematology, Oncology Pc | Pittsfield | Massachusetts | 01201 | — |
| Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan | 49503 | — |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | — |
| Southdale Cancer Clinic | Edina | Minnesota | 55414 | — |
| Coborn Cancer Center | Saint Cloud | Minnesota | 56303 | — |
| Metro-Minnesota Community Oncology Research Consortium | Saint Louis Park | Minnesota | 55416 | — |
| Jackson Oncology Associates, PLLC | Jackson | Mississippi | 39202 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Heartland CCOP/Missouri Baptist Medical Center | St Louis | Missouri | 63131 | — |
| Cancer Alliance of Nebraska | Lincoln | Nebraska | 68510 | — |
| Cancer Alliance of Nebraska | Omaha | Nebraska | 68106 | — |
| Dartmouth Hitchcock Med Center | Lebanon | New Hampshire | 03756 | — |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | — |
| New York Oncology Hematology, P.C. | Albany | New York | 12206 | — |
| Roswell Park Cancer Inst. | Buffalo | New York | 14263 | — |
| Mount Sinai Beth Israel Medical Center | New York | New York | 10003 | — |
| Mount Sinai Beth Israel Comprehensive Cancer Center | New York | New York | 10011 | — |
| Mount Sinai West | New York | New York | 10019 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| University of North Carolina-Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Carolina Oncology Specialists, PA - Hickory | Hickory | North Carolina | 28602 | — |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45242 | — |
| The Mark H. Zangmeister Ctr | Columbus | Ohio | 43219 | — |
| Dayton Clinical Oncology Prog | Dayton | Ohio | 45420 | — |
| Toledo Clinic Cancer Center | Toledo | Ohio | 43623-3536 | — |
| Northwest Cancer Specialists - Portland (NE Hoyt St) | Portland | Oregon | 97213 | — |
| Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | — |
| Albert Einstein Healthcare Network | Philadelphia | Pennsylvania | 19141 | — |
| Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | — |
| Charleston Oncology, P .A | Charleston | South Carolina | 29414 | — |
| Roper Bon Secours St. Francis Cancer Center | Charleston | South Carolina | 29414 | — |
| South Carolina Oncology Associates - SCRI | Columbia | South Carolina | 29210 | — |
| University of Missouri-Columbia | Columbia | South Carolina | 65203 | — |
| Cancer Centers of the Carolina | Greenville | South Carolina | 29615 | — |
| Sanford USD School of Medicine | Sioux Falls | South Dakota | 57104 | — |
| Tennessee Oncology , PLLC - Chattanooga | Chattanooga | Tennessee | 37403 | — |
| Tennessee Oncology - Nashville | Nashville | Tennessee | 37203 | — |
| Vanderbilt Breast Center at One Hundred Oaks | Nashville | Tennessee | 37204 | — |
| Texas Oncology-Medical City Dallas | Dallas | Texas | 75230 | — |
| Texas Oncology - DFW at Dallas Presbyterian Hospital | Dallas | Texas | 75231 | — |
| Texas Oncology - DFW | Dallas | Texas | 75246 | — |
| Texas Oncology-El Paso Cancer Treatment Center Grandview | El Paso | Texas | 79902 | — |
| Texas Oncology - DFW Fort Worth | Fort Worth | Texas | 76104 | — |
| The Center for Cancer and Blood Disorders - Fort Worth | Fort Worth | Texas | 76104 | — |
| Texas Oncology, P.A. - Garland | Garland | Texas | 77060 | — |
| Texas Oncology - Houston (Gessner) | Houston | Texas | 77024 | — |
| Cancer Care Centers of South Texas-HOAST - San Antonio | New Braunfels | Texas | 78130 | — |
| Texas Oncology - DFW Plano | Plano | Texas | 75075 | — |
| Texas Oncology-Tyler | Tyler | Texas | 75702 | — |
| Community Cancer Trials of Utah | Ogden | Utah | 84405 | — |
| Wellmonth Physician Services | Bristol | Virginia | 24201 | — |
| Virginia Cancer Institute | Richmond | Virginia | 23230 | — |
| Providence St. Mary Regional Cancer Center | Walla Walla | Washington | 99362 | — |
| West Virginia University Hospitals Inc | Morgantown | West Virginia | 26506-9162 | — |
| Green Bay Oncology/St. Mary?s Hospital | Green Bay | Wisconsin | 54301 | — |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | — |
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 432 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01358877, 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 Nov 28, 2025 · Synced Nov 5, 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 NCT01358877 live on ClinicalTrials.gov.