A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer
Public ClinicalTrials.gov record NCT00567190. 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 Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study was a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial conducted to investigate the use of pertuzumab in combination with trastuzumab and docetaxel as first-line treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Participants could have received one prior hormonal treatment for MBC. Participants may have received systemic breast cancer treatment in the neo-adjuvant or adjuvant setting, provided that the participant had experienced a disease-free interval (DFI) of greater than or equal to (≥)12 months from completion of adjuvant systemic treatment (excluding hormonal therapy) to metastatic diagnosis. Participants may have received trastuzumab and/or a taxane during the neo-adjuvant or adjuvant treatment. Participants were randomized in 1:1 ratio to receive either pertuzumab or placebo, along with trastuzumab and docetaxel once every 3 weeks (q3w), during the treatment phase of the study until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Participants in the Placebo arm were not allowed to receive open-label pertuzumab after discontinuation from study treatment. However, if any analysis of overall survival had met the predefined criteria for statistical significance, participants in the Placebo arm still on treatment were offered the option to receive open-label pertuzumab in addition to other study medications.
Study identification
- NCT ID
- NCT00567190
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 808 participants
Conditions and interventions
Conditions
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
- Feb 12, 2008 (Actual)
- Primary completion
- May 13, 2011 (Actual)
- Completion
- Nov 23, 2018 (Actual)
- Last update posted
- Dec 13, 2019
2008 – 2018
United States locations
- U.S. sites
- 159
- U.S. states
- 34
- U.S. cities
- 123
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HonorHealth Research Institute - Bisgrove | Scottsdale | Arizona | 85258 | — |
| NEA Baptist Clinic | Jonesboro | Arkansas | 72401 | — |
| Central Hematology Oncology Medical Group Inc. | Alhambra | California | 91801 | — |
| Pacific Cancer Medical Center | Anaheim | California | 92801 | — |
| Comprehensive Blood/Cancer Ctr | Bakersfield | California | 93309 | — |
| Kaiser Permanente - Baldwin Park | Baldwin Park | California | 91706 | — |
| Tower Cancer Research Foundation | Beverly Hills | California | 90211 | — |
| South Bay Oncology Hematology Partners | Campbell | California | 95008 | — |
| Wilshire Oncology Medical Group | Corona | California | 92879 | — |
| Compassionate Cancer Care | Fountain Valley | California | 92708 | — |
| Pacific Coast Hematology/Oncology Medical Group | Fountain Valley | California | 92708 | — |
| St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr | Fullerton | California | 92835 | — |
| Wilshire Onc Med Grp., Inc | Glendora | California | 91741 | — |
| Wilshire Oncology Medical Group | La Verne | California | 91750 | — |
| UCLA | Los Angeles | California | 90024 | — |
| LAC USC Medical Center | Los Angeles | California | 90033 | — |
| Cedars- Sinai Medical Center | Los Angeles | California | 90048 | — |
| Ronald Reagan UCLA Medical Center Clin Lab | Los Angeles | California | 90095 | — |
| TORI Central Administration | Los Angeles | California | 90095 | — |
| UCLA Hematology / Oncology Clinic | Los Angeles | California | 90095 | — |
| UCLA Med Ctr; Pharma Svcs | Los Angeles | California | 90095 | — |
| Sutter Gould Medical Foundation; Clinical Research | Modesto | California | 95355 | — |
| Kaiser Permanente - Oakland | Oakland | California | 94611 | — |
| Ventura County Hematology-Oncology Specialists | Oxnard | California | 93030 | — |
| UCLA Healthcare/Pasadena Oncology | Pasadena | California | 91105 | — |
| Wilshire Oncology Medical Group | Pasadena | California | 91750 | — |
| Bay Area Cancer Research Group, LLC | Pleasant Hill | California | 94523 | — |
| Wilshire Oncology Medical Group | Pomona | California | 91767 | — |
| Wilshire Oncology Medical Group | Rancho Cucamonga | California | 91730 | — |
| UC Davis Cancer Center; Oncology | Sacramento | California | 95817 | — |
| Kaiser Permanente San Diego; Hepatology Research | San Diego | California | 92154 | — |
| K. Permanente - San Fransisco | San Francisco | California | 94115 | — |
| K. Permanente - San Jose | San Jose | California | 95119 | — |
| Sansum Santa Barbara Medical Foundation Clinic | Santa Barbara | California | 93105 | — |
| Santa Barbara Hematology Oncology Medical Group, Inc. | Santa Barbara | California | 93105 | — |
| UCLA Hematology/Oncology | Santa Monica | California | 90404 | — |
| UCLA / Santa Clarita Valley Cancer Center | Valencia | California | 91355 | — |
| Kaiser Permanente - Vallejo | Vallejo | California | 94589 | — |
| K. Permanente - Walnut Creek | Walnut Creek | California | 94596 | — |
| Wilshire Oncology Medical Group | West Covina | California | 91790 | — |
| Innovative clinical research institute/American institute of research | Whittier | California | 90603 | — |
| Georgetown University Medical Center Lombardi Cancer Center | Washington D.C. | District of Columbia | 20007 | — |
| MedStar Washington Hosp Center | Washington D.C. | District of Columbia | 20010 | — |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | — |
| Boca Raton Comprehensive Cancer Center | Boca Raton | Florida | 33428 | — |
| Florida Cancer Specialists -Cape Coral (Cape Coral Pkwy) | Cape Coral | Florida | 33914 | — |
| Florida Cancer Specialists - Cape Coral (Del Prado Blvd) | Cape Coral | Florida | 33990 | — |
| Northwest Oncology/ Hematology Assoc. | Coral Springs | Florida | 33065-5701 | — |
| UM Sylvester Deerfield Beach; Sylvester Cancer Ctr | Deerfield Beach | Florida | 33442 | — |
| Florida Cancer Specialists - Englewood | Englewood | Florida | 34223 | — |
| Florida Cancer Specialists - Fort Myers (New Hampshire Ct) | Fort Myers | Florida | 33901-8101 | — |
| Florida Cancer Specialists - Broadway | Fort Myers | Florida | 33901 | — |
| Florida Cancer Specialists; SCRI | Fort Myers | Florida | 33901 | — |
| Florida Cancer Specialists-Broadway, Fort Myers | Fort Myers | Florida | 33908 | — |
| Private Practice Robert R. Carroll, Md, Pa | Gainesville | Florida | 32605 | — |
| Memorial Cancer Institute | Hollywood | Florida | 33021 | — |
| Memorial Regional Hospital | Hollywood | Florida | 33021 | — |
| Lakeland Regional Cancer Center | Lakeland | Florida | 33804-1057 | — |
| Jackson Memorial Hospital | Miami | Florida | 33136 | — |
| University of Miami School of Medicine | Miami | Florida | 33136 | — |
| Florida Cancer Specialists - Goodlette, Naples | Naples | Florida | 34102 | — |
| Florida Cancer Specialists - Pine Ridge, Naples | Naples | Florida | 34119 | — |
| Private Practice | Orlando | Florida | 32804 | — |
| Breast Cancer Centre at Memorial Hospital West | Pembroke Pines | Florida | 33028 | — |
| Florida Cancer Specialists - Port Charlotte | Port Charlotte | Florida | 33980 | — |
| Florida Cancer Specialists; Sarasota | Sarasota | Florida | 34232 | — |
| Bay Area Oncology | Tampa | Florida | 33607 | — |
| Florida Cancer Specialists - Venice (S. Tamiami Tr) | Venice | Florida | 33980 | — |
| Florida Cancer Specialists - Sunset Lake, Venice | Venice | Florida | 34292 | — |
| Cleveland Clinic Florida | Weston | Florida | 33331 | — |
| Northeast Georgia Medical Center; Oncology Research Dept-5C | Gainesville | Georgia | 30501 | — |
| Central Georgia Hematology Oncology Associates | Macon | Georgia | 31201 | — |
| Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital | Marietta | Georgia | 30060 | — |
| Central GA Cancer Care | Warner Robins | Georgia | 31088-2259 | — |
| Elmhurst Hospital | Elmhurst | Illinois | 60126 | — |
| Hematology Oncology Consultants Ltd | Naperville | Illinois | 60540 | — |
| Quincy Medical Group | Quincy | Illinois | 62301 | — |
| Midwestern Regional Medical Center; Office of Research | Zion | Illinois | 60099 | — |
| Monroe Medical Associates - Hobart | Hobart | Indiana | 46342 | — |
| St. Mary Medical Center | Hobart | Indiana | 46432 | — |
| Hematology-Oncology of Indiana, Pc | Indianapolis | Indiana | 46260 | — |
| Community Hospital; Pharmacy | Munster | Indiana | 46321 | — |
| Northwest Oncology | Munster | Indiana | 46321 | — |
| Monroe Medical Associates | Munster | Indiana | 46375 | — |
| Family Medicine Vincennes | Vincennes | Indiana | 47591 | — |
| Uni of Iowa Hospital&Clinic; Holden Comprehens. Cancer Ctr | Iowa City | Iowa | 52242 | — |
| University of Kansas; Medical Center & Medical pavilion | Westwood | Kansas | 66205 | — |
| Cancer Center of Kansas | Wichita | Kansas | 67214-3728 | — |
| Jewish Cancer Care | Louisville | Kentucky | 40245 | — |
| Cancer Center of Acadiana at Lafayette General | Lafayette | Louisiana | 70506 | — |
| Christus Schumpert Health System | Shreveport | Louisiana | 71101-1978 | — |
| Private Practice- Carolyn Hendricks, MD | Bethesda | Maryland | 20817 | — |
| Boston Medical Center | Boston | Massachusetts | 02118-2393 | — |
| Berkshire Hematology, Oncology Pc | Pittsfield | Massachusetts | 01201 | — |
| Cancer & Hematology Centers of Western Michigan | Grand Rapids | Michigan | 49503 | — |
| Cancer & Hematology Center of West Michigan | Grand Rapids | Michigan | 49546 | — |
| Oncology Care Associates PLLC | Saint Joseph | Michigan | 49085 | — |
| Southdale Cancer Clinic U of M Medical Center, Fairview- Edina | Edina | Minnesota | 55435 | — |
| US Oncology Research at Minnesota Oncology | Minneapolis | Minnesota | 55404 | — |
| Minneapolis Oncology Hamatology PA | Minneapolis | Minnesota | 55407-3799 | — |
| The Jones Clinic, PC | New Albany | Mississippi | 38652 | — |
| St. Vincent Frontier Cancer Center | Billings | Montana | 59101 | — |
| Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology | Lincoln | Nebraska | 68510 | — |
| Norfolk Oncology Consultants | Norfolk | Nebraska | 68701 | — |
| Hematology-Oncology Consultants, Pc | Omaha | Nebraska | 68122 | — |
| Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| St. Barnabas Cancer Center | Livingston | New Jersey | 07039 | — |
| Oncology and Hematology Specialists | Mountain Lakes | New Jersey | 07046 | — |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | — |
| Brockport-Interlakes Foundation | Brockport | New York | 14420 | — |
| Canandaigua-Interlakes Found | Canandaigua | New York | 14420 | — |
| Geneva-Interlakes Foundation | Geneva | New York | 14456 | — |
| ProHEALTH Care Associates LLP | Lake Success | New York | 11042 | — |
| Beth Israel Comprehensive Cancer Center Pharmacy | New York | New York | 10011 | — |
| The Women'sOncology & Wellness Practice | New York | New York | 10016 | — |
| Upstate Ny Cancer Research & Education Foundation | Rochester | New York | 14623 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Carolina Oncology Specialists, PA - Hickory | Hickory | North Carolina | 28602 | — |
| Carolina BioOncology Institute, PLCC | Huntersville | North Carolina | 28078 | — |
| NW Carolina Onc & Hem | Lenoir | North Carolina | 28645 | — |
| Gabrail Cancer Center | Canton | Ohio | 44718 | — |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45242 | — |
| Hema Onc Conslts-Grant Ave | Columbus | Ohio | 43215 | — |
| The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc. | Columbus | Ohio | 43219 | — |
| Hematology Onc Consultants | Columbus | Ohio | 43228 | — |
| Gabrail Cancer Center | Dover | Ohio | 44622 | — |
| Hematology Oncology Consultants (NWK) | Granville | Ohio | 43023 | — |
| Medical College of Ohio; Cancer Institute | Toledo | Ohio | 43614 | — |
| Mercy Physicians of Oklahoma | Oklahoma City | Oklahoma | 73120 | — |
| CA Care Associates-OK Oncology and Hematology | Tulsa | Oklahoma | 74104 | — |
| Cancer Care Assoc-S. Ingo | Tulsa | Oklahoma | 74133 | — |
| OK Oncology & Hematology PC | Tulsa | Oklahoma | 74136 | — |
| Cons in Med Onc and Hem | Darby | Pennsylvania | 19026 | — |
| Consultants in Medical Oncology/Hematology | Drexel Hill | Pennsylvania | 19026 | — |
| Armstrong County Memorial Hospital | Kittanning | Pennsylvania | 16201 | — |
| Conslts in Med Onc (Newtown); Bryn Mawr Health Canc Ctr | Newtown Square | Pennsylvania | 19073 | — |
| Uni of Pittsburgh; Magee-Women'S Hospital | Pittsburgh | Pennsylvania | 15213 | — |
| Consultants Med Onc & Hem | Ridley Park | Pennsylvania | 19078 | — |
| Erlanger Health System; Oncology Research | Chattanooga | Tennessee | 37403 | — |
| SCRI Tennessee Oncology Chattanooga | Chattanooga | Tennessee | 37404 | — |
| McLeod Cancer and Blood Center | Johnson City | Tennessee | 37604 | — |
| University of Tennessee Cancer Institute;Hem-Onc Consultants | Knoxville | Tennessee | 37920 | — |
| Sarah Cannon Cancer Center - Tennessee Oncology, Pllc | Nashville | Tennessee | 37203 | — |
| Park Plaza | Houston | Texas | 77004 | — |
| Southwest | Houston | Texas | 77008 | — |
| St. Joseph's | Houston | Texas | 77008 | — |
| Memorial City-Main Office | Houston | Texas | 77024 | — |
| Oncology Consultants | Houston | Texas | 77024 | — |
| St. Luke's | Houston | Texas | 77030 | — |
| Willowbrook | Houston | Texas | 77070 | — |
| Katy-Christus St. Catherine | Katy | Texas | 77450 | — |
| South Texas Oncology Hematology | San Antonio | Texas | 78258 | — |
| Oncology Consultants - Sugar Land | Sugar Land | Texas | 77479 | — |
| Northern Utah Associates | Ogden | Utah | 84403 | — |
| Community Cancer Center Rutland Regional Medical Center | Rutland | Vermont | 05701 | — |
| Wellmonth Physician Services | Bristol | Virginia | 24201 | — |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | — |
| St. Mary Medical Center | Walla Walla | Washington | 99362 | — |
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 163 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00567190, 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 Dec 13, 2019 · Synced Nov 5, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00567190 live on ClinicalTrials.gov.