A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer
Public ClinicalTrials.gov record NCT01966471. 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, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus a Taxane Following Anthracyclines Versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines 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 two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane.
Study identification
- NCT ID
- NCT01966471
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,846 participants
Conditions and interventions
Conditions
Interventions
- Trastuzumab Emtansine Drug
- Trastuzumab Drug
- Pertuzumab Drug
- Paclitaxel Drug
- Epirubicin Drug
- Doxorubicin Drug
- Docetaxel Drug
- Cyclophosphamide Drug
- 5-Fluorouracil 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
- Jan 30, 2014
- Primary completion
- Nov 26, 2019
- Completion
- Jun 3, 2021
- Last update posted
- Jun 13, 2022
2014 – 2021
United States locations
- U.S. sites
- 50
- U.S. states
- 23
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HonorHealth Research Institute - Bisgrove | Scottsdale | Arizona | 85258 | — |
| Kaiser Permanente - Oakland | Oakland | California | 94611 | — |
| Kaiser Permanente - Roseville; Oncology Pharmacy | Roseville | California | 95661 | — |
| Kaiser Permanente - Sacramento; Oncology Pharmacy | Sacramento | California | 95814 | — |
| UC Davis Cancer Center; Oncology | Sacramento | California | 95817 | — |
| Southern California Kaiser Permanente | San Diego | California | 92108 | — |
| Kaiser Permanente - San Jose | San Jose | California | 95119 | — |
| Kaiser Permanente - San Leandro | San Leandro | California | 94577 | — |
| Kaiser Permanente - South SF; Oncology Clinical trials | South San Francisco | California | 94080 | — |
| Stanford University School of Medicine | Stanford | California | 94305-5151 | — |
| Kaiser Permanente - Vallejo | Vallejo | California | 94589 | — |
| Kaiser Permanente - Walnut Creek; Oncology Pharmacy | Walnut Creek | California | 94596 | — |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | — |
| Florida Cancer Specialists; SCRI | Fort Myers | Florida | 33901 | — |
| Florida Cancer Specialists; Saint Petersburg | St. Petersburg | Florida | 33719 | — |
| University Cancer & Blood Center, LLC; Research | Athens | Georgia | 30607 | — |
| Georgia Cancer Specialists | Atlanta | Georgia | 30341 | — |
| Central Georgia Cancer Care PC | Macon | Georgia | 31201 | — |
| Quincy Medical Group; Canc Ctr at Blessing Hosp | Quincy | Illinois | 62301 | — |
| Carle Cancer Center | Urbana | Illinois | 61801 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Cancer Center of Kansas | Wichita | Kansas | 67214-3728 | — |
| Anne Arundel Health System Research Instit-Annapolis Oncology Ctr | Annapolis | Maryland | 21401 | — |
| Mercy Medical Center | Baltimore | Maryland | 21202 | — |
| Dana Farber Cancer Inst. | Boston | Massachusetts | 02115 | — |
| Beth Israel Deaconess Med Ctr | Boston | Massachusetts | 02215 | — |
| Karmanos Cancer Institute.. | Detroit | Michigan | 48201 | — |
| Henry Ford Hospital; Hematology Oncology | Detroit | Michigan | 48202 | — |
| US oncology research at Minnesota Oncology | Saint Paul | Minnesota | 55102 | — |
| Mercy Medical Research Institute | Springfield | Missouri | 65807 | — |
| Dartmouth Hitchcock Med Center | Lebanon | New Hampshire | 03756 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | — |
| Memorial Sloan-Kettering Cancer Center | Commack | New York | 11725 | — |
| ProHEALTH Care Associates LLP | Lake Success | New York | 11042 | — |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Cone Health Cancer Center | Greensboro | North Carolina | 27403 | — |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45242 | — |
| Mercy Clinic Oklahoma Communties, Inc | Oklahoma City | Oklahoma | 73120 | — |
| Magee-Woman's Hospital | Pittsburgh | Pennsylvania | 15213 | — |
| SCRI Tennessee Oncology Chattanooga | Chattanooga | Tennessee | 37404 | — |
| West Clinic | Germantown | Tennessee | 38138 | — |
| Thompson Cancer Survival Center | Knoxville | Tennessee | 37916-2305 | — |
| Sarah Cannon Cancer Center - Tennessee Oncology, Pllc | Nashville | Tennessee | 37203 | — |
| The Center for Cancer and Blood Disorders - Fort Worth | Fort Worth | Texas | 76104 | — |
| Wellmont Medical Associates | Bristol | Virginia | 24201 | — |
| University of Virginia Health System; Hematology/Oncology Division | Charlottesville | Virginia | 22908 | — |
| Virginia Commonwealth University - Massey Cancer Center | Richmond | Virginia | 23298 | — |
| Blue Ridge Cancer Care - Salem | Salem | Virginia | 24153 | — |
| University of Washington | Seattle | Washington | 98195 | — |
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 245 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01966471, 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 13, 2022 · Synced Sep 24, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01966471 live on ClinicalTrials.gov.