A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)
Public ClinicalTrials.gov record NCT01772472. 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 Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.
Study identification
- NCT ID
- NCT01772472
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,486 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
- Apr 3, 2013 (Actual)
- Primary completion
- Jul 25, 2018 (Actual)
- Completion
- May 23, 2024 (Actual)
- Last update posted
- Jul 22, 2025
2013 – 2024
United States locations
- U.S. sites
- 60
- U.S. states
- 27
- U.S. cities
- 52
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | — |
| Todd Cancer Institute at Long Beach Memorial Medical Center | Long Beach | California | 90806 | — |
| Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| Stanford University Medical Center | Palo Alto | California | 94304 | — |
| Kaiser Permanente - San Diego | San Diego | California | 92120 | — |
| Breastlink Medical Group Inc | Santa Ana | California | 92705 | — |
| Kaiser Permanente - Vallejo | Vallejo | California | 94589 | — |
| Kaiser Permanente - Franklin | Denver | Colorado | 80205 | — |
| Colorado Cancer Research Program/Admin | Denver | Colorado | 80222 | — |
| Yale Cancer Center | New Haven | Connecticut | 06510-3221 | — |
| Washington Cancer Institute | Washington D.C. | District of Columbia | 20010 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | — |
| UF Health Orlando | Orlando | Florida | 32806 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612-9497 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Edward Cancer Center Naperville | Naperville | Illinois | 60540 | — |
| Edward Cancer Center Plainfield | Plainfield | Illinois | 60585 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | — |
| Norton Healthcare Inc. | Louisville | Kentucky | 40202 | — |
| Cancer Care of Maine | Brewer | Maine | 04412 | — |
| New England Cancer Specialists | Scarborough | Maine | 04074 | — |
| Mercy Medical Center | Baltimore | Maryland | 21202 | — |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | — |
| Med Star Franklin Square Medical Center/Weinburg Cancer Institute | Baltimore | Maryland | 21237 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Spectrum Health Hospitals | Grand Rapids | Michigan | 49503 | — |
| Breslin Cancer Center | Lansing | Michigan | 48910 | — |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
| US oncology research at Minnesota Oncology | Saint Louis Park | Minnesota | 55426 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | — |
| Sparta Cancer Center | Sparta | New Jersey | 07871-1791 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Troy Cancer Treatment Program | Troy | New York | 12180 | — |
| Carolinas Medical Center | Charlotte | North Carolina | 28204-2839 | — |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58122-9988 | — |
| Aultman Hospital | Canton | Ohio | 44710 | — |
| Fairview Hospital | Cleveland | Ohio | 44111 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ohio State University, Arthur James Cancer Hospital | Columbus | Ohio | 43210 | — |
| Columbia River Oncology Program | Portland | Oregon | 97225 | — |
| Kimmel Cancer Center Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Allegheny Cancer Center | Pittsburgh | Pennsylvania | 15212 | — |
| Uni of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| York Hospital | York | Pennsylvania | 17403 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | — |
| Thompson Cancer Survival Center | Knoxville | Tennessee | 37916-2305 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Houston Methodist Hospital Outpatient Center | Houston | Texas | 77030 | — |
| Uni of Texas - Md Anderson Cancer Center | Houston | Texas | 77030 | — |
| Joe Arrington Cancer Research & Treatment Center | Lubbock | Texas | 79410 | — |
| Hematology Oncology Associates of Fredericksburg, Inc. | Fredericksburg | Virginia | 22408 | — |
| Centra Alan B. Pearson Regional Cancer Center | Lynchburg | Virginia | 24501 | — |
| Virginia Commonwealth University - Massey Cancer Center | Richmond | Virginia | 23298 | — |
| Swedish Cancer Institute - Issaquah | Issaquah | Washington | 98029 | — |
| Cancer Care Northwest | Spokane | Washington | 99204 | — |
| 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 208 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01772472, 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 Jul 22, 2025 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01772472 live on ClinicalTrials.gov.